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Applied Statistics for FDA Process Validation 2017

2017-07-20T06:30:57.780Z

Course "Applied Statistics for FDA Process Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle:

Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.

Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.

Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control.

The first stage of process validation is process design. The Process Validation guidance document states, "A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Manufactures should:

Understand the sources of variation
Detect the presence and degree of variation
Understand the impact of variation on the process and ultimately on product attributes
Control the variation in a manner commensurate with the risk it represents to the process and product."

The second stage of process validation is process qualification. Although stage 2 has two elements, this course will focus on recommendations for the second element, PPQ. PPQ "combines the actual facility, utilities, equipment (each now qualified), and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches." Additionally, the process validation guidance document that "Each manufacturer should judge whether it has gained sufficient understanding to provide a high degree of assurance in its manufacturing process to justify commercial distribution of the product. Focusing exclusively on qualification efforts without understanding the manufacturing process and associated variations may not lead to adequate assurance of quality."

The third stage of process validation is continued process verification. The process validation guidance document defines the need for this stage: "After establishing and confirming the process, manufacturers must maintain the process in a state of control over the life of the process, even as materials, equipment, production environment, personnel, and manufacturing procedures change." Manufacturers should use ongoing programs to collect and analyze product and process data to evaluate the state of control of the process. These programs may identify process or product problems or opportunities for process improvements that can be evaluated and implemented through some of the activities described in Stages 1 and 2."

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. Methods taught through all three stages are recommended by regulatory guidance documents; references to the specific citations in the guidance documents are provided.

Why should you attend:

The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled "Process Validation: General Principles and Practices" consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification.

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process development and validation program consistent with the FDA guidance. This course teaches the application of statistics for setting specifications, assessing measurement systems (assays), using design of experiments (DOE), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although established for the pharmaceutical industry, it also provides a useful framework for other industries.

Analyses in this course use the point-and-click interface of JMP software by SAS.

Areas Covered in the Session:

apply statistics to set specifications and validate measurement systems (assays)
develop appropriate sample plans based on confidence and power
implement suitable statistical methods into a process validation program for each of the three stages
Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

Who Will Benefit:

This seminar is designed for pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control.

Process Scientist/Engineer
Design Engineer
Product Development Engineer
Regulatory/Compliance Professional
Design Controls Engineer
Six Sigma Green Belt
Six Sigma Black Belt
Continuous Improvement Manager

Agenda:

Day 1 Schedule

Lecture 1:

Introduction to Statistics for Process Validation

principles of process validation
stages of process validation

Primer on Statistical Analysis

basic statistics

Lecture 2:

Primer on Statistical Analysis (cont.)

statistical intervals and hypothesis testing

Lecture 3:

Primer on Statistical Analysis (cont.)

statistical intervals and hypothesis testing
ANOVA

Lecture 4:

Primer on Statistical Analysis (cont.)

regression
run charts

Day 2 Schedule

Lecture 1:

Foundational Requirements for Process Validation

setting specifications
analytical methodology

Stage 1 - Process Design

steps to DOE
screening designs

Lecture 2:

Stage 1 - Process Design

response surface designs
establishing a strategy for process qualification

Lecture 3:

Stage 2 - Process Qualification

introduction
incorporation of large-scale data
development of PPQ acceptance criteria
development of sampling plans

Lecture 4:

Stage 3 - Continued Process Verification

statistical process control
process capability

Speaker:

Richard (Rick) K. Burdick

Location: Baltimore, MD Date: September 18th & 19th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901142SEMINAR?doctorshangout-September-2017-SEO

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Compliance Boot Camp 2017

2017-07-20T06:28:39.074Z

Course "Compliance Boot Camp" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This 2-day seminar will cover the essentials of compliance for medical device companies. An efficient and effective quality system can be a competitive advantage for companies by leading to improved quality and compliance as well as optimizing the cost of quality. This "Compliance Boot Camp" will get you started in setting up just such a Quality System. We'll discuss the "case for quality" and how you can use compliance, not as an end itself, but as a means to improved quality and reduced cost of non-compliance.

In this seminar, we will discuss:

Regulatory Expectations
How to plan, structure, and implement a quality system
Common problems and lessons from 483 and warning letters
Red-flags that your QS is not effective
Audit for self-awareness
Risk analysis and management techniques
CAPA, continuous improvement, and six sigma
Performance monitoring
Culture, Management Responsibility, and maturity
Key Quality System elements and linkages

Why should you attend:

This seminar will help you understand regulatory requirements and how to translate them into a quality system that is both effective and efficient. You'll learn how to plan, structure, and implement a quality system specific for your business needs. We'll explore the capabilities that every medical device company needs to ensure quality products and a compliant quality system. We'll discuss how to create a quality strategy and plans. Will discuss methods to identify, prioritize, and analyze risks. Then will move on to continuous improvement, six sigma, and Corrective and Preventive Action to address issues within your Quality System. You'll learn how to effectively communicate and escalate risk as well as monitor performance and progress.

This seminar can help you get your quality system off to a good start and avoid common problems including MDRs, recalls, 483s, and warning letters!

The expectations for quality and compliance continue to increase. We will discuss changing regulations and expectations and what you can do to prepare for them. This seminar will allow you to interact personally with an industry expert with over 30 years' experience in medical devices. The instructor has worked in manufacturing, design, quality and compliance at industry leaders like GE, Johnson and Johnson, and Medtronic. She has traveled throughout the world developing, auditing, and improving quality systems.

Learning Objectives:

This 2-day seminar will cover the following areas:

Quality System Expectations
Quality System Structure
Strategy and Planning
Risk management in your quality system
Case for Quality
Inspection preparedness and management
Monitoring and metrics
Creating a quality strategy and plans

Who will benefit:

Quality Systems Specialists
Document Control Specialists
Quality and Compliance Specialists
Auditors
Auditor Managers
Compliance Managers
Quality Managers
CAPA Specialists
Quality and Compliance directors for Medical Device companies
General Managers and Executives wanting to use Compliance and Quality as a competitive strength

Agenda:

Day 1 Schedule

Lecture 1:

Overview

Lecture 2:

Introductions

Lecture 3:

Regulatory expectations

Lecture 4:

Quality Systems requirements for medical devices

Lecture 5:

Quality System structure and writing SOPs

Lecture 6:

Roles and Responsibilities

Lecture 7:

Management Responsibility and a Culture of Quality

Lecture 8:

Cost of Quality

Lecture 9:

Key Capabilities for Success

Lecture 10:

Metrics and performance monitoring

Lecture 11:

Maturity Modeling

Day 2 Schedule

Lecture 1:

An effective auditing program is a key to self-awareness

Lecture 2:

CAPA and root cause analysis - essentials for improvement

Lecture 3:

Six Sigma for Quality and Compliance

Lecture 4:

Management Review

Lecture 5:

Inspection preparedness and management

Lecture 6:

Red Flags and Warning Signs

Lecture 7:

Best Practices

Lecture 8:

Risk Management for Compliance

Lecture 9:

Creating a strategy and quality plan

Speaker:

Susanne Manz

Quality and Compliance Expert / Auditor for Medical Devices, Manz Consulting, Inc.

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at industry leaders like GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, Worldwide Director of Quality Engineering, Worldwide Director of Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world conducting audits and helping companies to understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and has a BS in Biomedical Engineering and an MBA from the University of NM.

She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link -http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901150SEMINAR?doctorshangout-September-2017-SEO

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

FDA FSMA Rules & Planning Valid Preventive Food Safety Controls 2017

2017-07-20T06:26:53.642Z

Course "Preparing to Comply with the New FDA FSMA Rules: Planning Valid Preventive Food Safety Controls" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Upon completing this course participants will leave with a preliminary preventive control implementation plan and will:

Understand US FDA final rules for the Preventive Controls for Human and Animal Foods
Define and review your current system to identify gaps in your preventive controls planning.
Be able to develop and implement a valid preventive control company food safety plan to close any gaps
Write and implement appropriate procedures.
Know your requirements for control over your supply chain
Be able to plan and implement HARPC
Be able to perform environmental monitoring
Know how cross contamination can impact your preventive control plan
Know the difference between validation and verification
Understand and be able to use statistical process controls basics
Be able to plan and implement a team approach to preventive controls
Be able to help your food importers to jump through FDA hoops
Develop a system to risk rank your suppliers
Have a plan in hand that will pass any validation check for preventive controls
Understand some of the technology and costs that can help you establish preventive controls
Prove that your system actually prevents food safety problems
Be able to document and report results to upper management, external food safety auditors and FDA auditors
Save your company money Establish simple, low cost complete data collection and reporting systems.
Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system
Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures
Learn how to use your system to get some ROI and improve your marketing position
Review current and future technologies designed to improve and simplify data collection
Establish a completely documented system

Why should you attend:

Validation of preventive controls is where the rubber meets the road in terms of prevention. You can develop a food safety plan, implement the plan and verify the plan, but if your data does not prove that you are actually preventing food safety problems, the plan is not considered valid and your overall food safety effort will fail audits.

According to the FDA all food facilities "must monitor their controls, conduct verification activities, provide hard data to validate that the controls are effective, take appropriate corrective actions, and maintain records documenting these actions". This training session will present a practical approach to provide you and your team members with needed understanding and tools and a basic strategy for designing, implementing and validating preventive process controls.

You will develop a basic plan during this training and have it checked by the instructor.

Regardless of your ability to understand or validate processes, process validation is now a legal requirement and you cannot wait for the FDA to develop their ability to assist your company

Areas Covered in the Session:

Preventive Control System Planning Requirements and Goals
Review of the FDA's FSMA Overall Rules
Review of final rules for the preventive control of human and animal foods
- Validation
- Environmental Monitoring (Sampling/Test/Labs/Data)
- Supply Chain Controls (Including imports)
- cGMP
Hazards and Adulteration
Prevention versus Corrective Action
Cross Contamination through Supply Chains
Food Safety and Quality Planning (HARPC)
Packaging
Teams and Teamwork
Continuous Improvement
Measurement, Repeatability, Reliability, Calibration
Statistical Process Control (SPC)
Data, logs, forms and electronic record keeping
Recall and Traceability
Return on investment (ROI) and marketing advantages
Integrated Food Safety Systems (Government vs Business needs)
Transportation Processes
Customers

Who Will Benefit:

Mandatory for upper level management needing to understand impact of laws relating to food safety program validation
Legal team members focused on food safety
Food quality and safety personnel
Food safety leads and implementation team members
Maintenance operations personnel
Food facility personnel
Food importers whose food will be consumed in the U.S.
Food security personnel
Recall specialists
Company sales and marketing personnel whose customers demand sanitary and temperature controlled distribution and transportation processes

Agenda:

Day 1 Schedule

Lecture 1:

Preventive Control System Planning Requirements and Goals Preventive Control System Planning Requirements and Goals
Review of the FDA's FSMA Overall Rules
Review of final rules for the preventive control of human and animal foods
Validation

Lecture 2:

Environmental Monitoring (Sampling/Test/Labs/Data)
Supply Chain Controls (including Imported Foods)
c/GMP

Lecture 3:

Hazards and Adulteration
Prevention versus Corrective Action
Cross Contamination through Supply Chains

Lecture 4: System Planning Activities

Day 2 Schedule

Lecture 1:

HARPC Food Safety and Quality Planning
Packaging

Lecture 2:

Teams, Teamwork and Continuous Improvement
Measurement, repeatability, Reliability, Calibration
Statistical Process Control

Lecture 3:

Data, logs, forms and electronic record keeping
Recall and Traceability
ROI
Integrated Food Safety Systems (Government versus Business)

Lecture 4:

Transportation Processes
Customers
System Planning

Speaker

John Ryan

President , TransCert , QualityInFoodSafety , RyanSystems

Dr. John Ryan's quality system career has spanned the manufacturing, food, transportation and Internet industries over the past 30 years. He has worked and lived extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turn-around specialist. His clients have included Seagate Technology, Read-Rite, Destron IDI, Intel, and GSS-Array. He has consulted, taught at the university graduate level, and is a retired quality assurance administrator from the Hawaii State Department of Agriculture. He holds a Ph.D. and has been involved in the quality profession for over 30 years on an international basis and in a variety of industries. He designed and piloted the United States first RFID enabled farm to retail traceability system in the nation while working with Motorola, Lowry Systems and other well-known industry companies. He has published over forty papers on quality systems and has recently published a book for Elsevier Press entitled "Guide to Food Safety and Quality During Transportation: Controls, Standards and Practices". He previously published "The Quality Team Concept in Total Quality Control" with the American Society for Quality. He began Ryan Systems over ten years ago.

Ryan Systems works with some of the world's leading equipment, hardware, software, training and integration companies in the business. We are closely connected with food safety and other audit activities and can begin an initial assessment of your capabilities and needs. Ryan Systems works with partners whose products have proven themselves to be positioned for future quality system needs.

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON, San Diego, CA

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901120SEMINAR?doctorshangout-September-2017-SEO

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Supplier Management in FDA- and ISO-regulated Industry 2017

2017-07-20T06:25:27.982Z

Course "Supplier Management in FDA- and ISO-regulated Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Supplier qualification and assessment is required in both the QSR regulations and ISO standards. Many companies spend a great deal of time and money in pursuit of compliance. Many companies can spend significantly less time and money, and still be in control of their suppliers and in compliance with the regulations. This class will review the QSR and ISO requirements for supplier evaluation, including defining the types of suppliers that require evaluation. The QSR/ISO requirements for supplier assessment will be defined as well. Attention will be paid to inclusion of risk management in across both supplier qualification and assessment, implementation of which will allow your company to devote value-added resources to these efforts. Significant time will be spent on discussion of the topic of supplier nonconformance, including how and when to issue the dreaded Supplier Corrective Action Request. Your supplier nonconformance handling process must be nonconfrontational, or even better, collaborative. If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain folks.

Why should you attend

Notified bodies and the FDA cannot require your suppliers to meet the quality system regulations, so they must make sure you are exercising sufficient control over those suppliers. You must make sure your supplier management and system meets all required regulations and guidance documents, especially for outsourced processes such as contract manufacturing, sterilization and testing, and also for critical suppliers. Sure, you depend on your suppliers to provide you with goods and services, but can your system prove that you have sufficient control over your suppliers to assure auditors and regulatory agencies that your product is safe and meets all your requirements? Your supplier management program can be in compliance, but is it cost effective? If not, your unquantifiable overhead costs may be out of control. Is your supplier management program collaborative with your suppliers? If your company is too demanding of your suppliers, you risk alienating them or even worse losing them - try explaining that to your supply chain folks!

Areas Covered in the Session:

Supplier Selection
- Review of FDA requirements
- Review of ISO requirements
- Types of suppliers that must be qualified
- Defining critical suppliers
- Outsourced processes
- Recommended Practices
- Documentation requirements
- Use of Risk Assessment
- The Quality Agreement
- Common Pitfalls
Supplier Assessment
- Review of FDA requirements
- Review of ISO requirements
- Case Study: A Hypothetical Supplier Assessment
- Recommended Practices
- Documentation requirements
- Use of Risk Assessment
- Common Pitfalls
Supplier Nonconformance
- Types of supplier nonconformances
  - Best Practices for Notification
  - Best Practices for Handling
  - Trending
  - Evaluation of Supplier Response
  - Tracking effectiveness
- Supplier Corrective Action Requests
  - Pre-notification?
  - Best Practices for Issuance
  - Followup
  - Evaluation/Acceptance of Supplier Response
  - Tracking effectiveness
Workshop: Review of Supplier Responses: Acceptable or UNacceptable?

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that are interested in implementing and maintaining a supplier management program that is both compliant and cost-efficient. The employees who will benefit include:

Supply chain management
Buyers
Purchasing management
CAPA Coordinators
Regulatory management
QA management
Executive management
Internal auditors

Agenda:

Day 1 Schedule

Lecture 1: Introduction
Supplier Selection

Review of FDA requirements
Review of ISO requirements
Types of suppliers that must be qualified
Defining critical suppliers
Outsourced processes

Lecture 2:
Supplier Selection (cont)

Recommended Practices
Documentation requirements
Use of Risk Assessment
The Quality Agreement
Common Pitfalls

Lecture 3:
Supplier Assessment

Review of FDA requirements
Review of ISO requirements
Case Study: A Hypothetical Supplier Assessment
Recommended Practices

Lecture 4:
Supplier Assessment (cont)

Documentation requirements
Use of Risk Assessment
Common Pitfalls

Day 2 Schedule

Lecture 1:
Supplier Nonconformance

Types of supplier nonconformances
- Best Practices for Handling
- Best Practices for Notification
- Trending
- Evaluation of Supplier Response
- Tracking effectiveness

Lecture 2:
Supplier Nonconformance (cont)

Supplier Corrective Action Requests
- Pre-notification?
- Best Practices for Issuance
- Followup
- Evaluation/Acceptance of Supplier Response
- Tracking effectiveness

Lecture 3:
Workshop

Acceptability of Supplier Responses

Lecture 4:
Q&A - Conclusion

Speaker

Jeff Kasoff

Director of Regulatory Affairs, Life-Tech, Inc

Jeff Kasoff, RAC, CMQ/OE has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS , his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 4:00 PM

Venue: DoubleTree by Hilton San Diego Downtown 1646 Front St, San Diego, CA 92101, USA

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901002SEMINAR?doctorshangout-September-2017-SEO

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Microbial Control, Monitoring, Validation and Troubleshooting 2017

2017-07-20T06:24:02.123Z

Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.

Why you should attend:

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

Who Will Benefit:

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
Quality Assurance personnel responsible for water system deviation management and change control
Regulatory and Compliance professionals responsible for FDA interactions
Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation
Facility Engineers responsible for water system design or renovation
Validation personnel for water system qualification
Change Control personnel involved in water system changes and repairs
Production Managers involved with water system use for manufacturing and cleaning
Laboratory Managers and Supervisors responsible for lab water systems and other water sources

Agenda:

Day 1 Schedule

Lecture 1:

What Makes Water Systems Have Microbial Quality Problems

Understand biofilm basics and how it develops
Understand the impact of biofilm on the commonly used purification unit operations
Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
Understand the how, where, and why of microbial monitoring, action levels, etc.
Debunk a few water system myths
Get answers to your own water system questions

Lecture 2:

Successful Sanitization Approaches for Trouble-Free Water Quality

Material and construction limitations
Continuous vs intermittent sanitization
The importance of biofilm removal
How sanitants work (or don't work)
When to sanitize
Troubleshooting sanitization problems

Lecture 3:

Water System Validation by Logic Instead of Tradition

Why validate a water system?
Basic ground rules for water systems before you validate them
Micro Test Method "validation"
Minimum validation expectations
How to figure out what you should validate
What happens after the honeymoon is over
Is validation ever really over?
Special considerations for lab water systems
Are packaged waters a viable option?

Lecture 4:

Implementing Changes to a Validated System

Purpose of a Change Control program - a help, not a hindrance
When is a change major vs minor, requiring full vs limited re-qualification?
What about water use during re-qualifications?
FDA validation expectations
Reliance on logic and common sense and the disservice of precedent and paradigms
Additional useful tips

Lecture 5:

Reducing Water Microbial Excursions & Improving Investigations

What are excursions?
Water system dilemma: process control or quality control (utility or raw material), or both
Intended roles of Alert/Action Levels and Specifications
Investigation, necessary and often fruitless
Excursion responses and impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Minimizing unnecessary excursion responses through best practices

Day 2 Schedule

Lecture 6:

Understanding and Controlling Endotoxin

Where does endotoxin come from?
What are the properties of endotoxin?
How do you get rid of it?
How do you detect it?
What assay controls are used?
What are the endotoxin specs for water?
How do you control it?

Lecture 7:

Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

Water harmonization that has occurred
Water Micro TM "Dis-Harmonization"
A little about Biofilm
Biofilm diversity in water systems
Micro TM options and evaluation protocol
The good and bad of Micro harmonization
Where RMMs can fit in
Parting wisdom

Lecture 8:

Microbial Enumeration Issues with High Purity Water Systems

Microbial Enumeration Issues with High Purity Water Systems
Biofilm enumeration issues (planktonic vs surface)
Traditional cultivative approach issues
Validation of your test method
Alternative TM choices (advantages/disadvantages)
Significance of water isolates
Sampling issues
Establishing Alert/Action Levels and Water Specs and defending them to FDA

Lecture 9:

Water System Investigation "How-To's" and Example Case Studies

Gathering and assessing existing data and symptoms
Considering user opinions
Investigation approach elements
Recognizing red herrings/false positives
Recognizing possible root causes
Water system contamination case studies
Parting kernels of water system wisdom

Lecture 10:

What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues

PW, WFI, Pure Steam micro specifications?
<1231> Starting water issues
<1231> Misunderstood issues clarified
<1231> Microbiological test issues clarified
<1231> Suggested micro test method
<1231> Micro Specifications
<1231> Alert and Action Levels and max's
Recent/Upcoming USP water changes
Discrepancies between pharmacopeia's

Speaker

Teri C. Soli

Principal Consultant, Soli Pharma Solutions

Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli's career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP's Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE's Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

Location: Shanghai, China Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON, Shanghai, China

Price:

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 09, Regular Price: $1,895.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link -http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901124SEMINAR?doctorshangout-September-2017-SEO

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Regulatory Requirements and Principles for Cleaning Validation 2017

2017-07-20T06:22:18.633Z

Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors.

The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.

Why you should attend:

Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.

Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.

Areas Covered in the Session:

Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies

Who Will Benefit:

Senior Quality Managers
Quality Professionals
Production Supervisors
Validation Engineers
Process Owners
Quality Engineers
Quality Auditors

Agenda:

Day 1 Schedule

Lecture 1:

FDA Requirements and Industry Standard Practices

Lecture 2:

How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and Parameters

Lecture 3:

How to Develop a Cleaning Validation Policy/Program

Lecture 4:

How to Implement a Robust Cleaning Validation Plan

Day 2 Schedule

Lecture 1:

Laboratory Issues in Cleaning

Lecture 2:

Microbiological aspects of a cleaning validation program for manufacturing equipment

Lecture 3:

Keys to Cleaning Validation Maintenance - Remaining Compliant

Lecture 4:

Current FDA concerns about validation of cleaning processes

Speaker

Joy McElroy

Principle Consultant, Maynard Consulting Company

Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.

Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.

Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing

Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON, San Diego, CA

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901170SEMINAR?doctorshangout-September-2017-SEO

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The EU General Data Protection Regulation (GDPR) 2017

2017-07-20T06:19:57.906Z

Course "The EU General Data Protection Regulation (GDPR)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

On 25th May 2018 the EU-GDPR becomes effective, this date has been set to give organisations time to prepare and comply with the regulations. This may seem to be a long way off, but for most organisations there is a lot to be done.

With the escalation of data breaches, the sooner data is safe guarded the better. Often a data breach is not discovered for months, sometimes six months, implementing new policies, security systems, negotiations with suppliers and training people in an organisation will take time. The sooner you start the more time you have to make a good decision on the options you face.

This introductory course will give you an overview of the history of Data Protection within the EU and introduce you to the enhancements and new obligations imposed by the EU GDPR.

Why you should attend:

Data protection law in the EU is about to undergo the most significant changes since the 1995 EU Data Protection Directive. The new EU General Data Protection Regulation (GDPR) came into effect in May 2016 and you have until May 2018 to become fully compliant. The new law will require significant preparatory work that you should begin now.

Will the EU GDPR apply to my business?

Does your organisation acquire, store, process, distribute, manage, modify or analyse any data which can be used to identify an EU citizen OR does your organisation trade with EU citizens?

If you answered YES, then no matter whether your organisation is based in the EU or elsewhere in the world, then the EU GDPR will apply to your business. Even though the EU-GDPR is an EU regulation, it has a global reach. If an organisation is outside of the EU it MUST still comply IF it handles, stores, manages, or processes EU citizens' personal data.

The new Regulation will impose many legal obligations on organisations that control or process data and will afford new rights to those whose personal data is being held. The financial penalties for non-compliance will be very substantial so it is absolutely vital that your organisation is fully prepared as early as possible.

Areas Covered in the Session:

Key definitions
Bands of penalties and range of awards for breaches
Timeline to application of GDPR
Six data protection principles, lawfulness and consent
Sensitive data
Rights of data subjects
Controllers and processors
Data protection by design
Securing personal data
Reporting data breaches
Transferring personal data outside the EU
Powers of supervisory authorities
Role of the EDPB (European Data Protection Board)

Who Will Benefit:

Directors
Company Secretaries
Compliance Officers
HR Staff
IT Admin
Any employee with a responsibility for managing data

Agenda:

Day 1 Schedule

Lecture 1:

GDPR Context, Definitions and Penalties

Determine what type of personal information is subject to the GDPR
Determine the organisational and geographic scope of the GDPR
Correctly define terms from the GDPR
Identify where data subjects have a right to lodge a complaint with respect to data processing

Lecture 2:

GDPR Context, Definitions and Penalties (Cont.)

Identify rights of a data subject to compensation
Identify the infringements that will be subject to fines of up to 2% of annual turnover
Identify the infringements that will be subject to fines of up to 4% of annual turnover
Identify the date on which the GDPR comes into force across the EU

Lecture 3:

GDPR Principles

the six principles for the processing of personal data
how to demonstrate compliance with each of the six principles
how controllers can demonstrate compliance
lawful grounds for processing data
the legal conditions for consent
the additional conditions necessary for a child's consent
which special categories of data may not be processed
the circumstances in which special data may be processed

Lecture 4:

Rights of Data Subjects

Identify the tests to respond transparently to data subject requests
Identify the requirements on controllers when obtaining personal data
Identify actions necessary in respect of personal data not obtained directly from data subjects
Identify a data subject's rights of access
Identify the grounds that give the right to be forgotten
Identify the grounds that give the right to restrict processing
Identify a data subject's right to data portability
Identify a data subject's right to object to processing

Day 2 Schedule

Lecture 1:

Controller and Processor

Differentiate between controllers and processors
Identify requirements on controllers in respect of processing activities
Identify how organisations are required to approach data protection by design
Identify the requirements in respect of controllers or processors who are not established in the EU
Identify the obligations applied to processors

Lecture 2:

Transfers of personal data

Identify the principles covering the transfer of personal data outside the EU
Identify where the EU posts details of organisations and/or countries that meet its adequacy test
Identify the requirements in respect of binding corporate rules

Lecture 3:

Supervisory authorities

Identify the powers of supervisory authorities
Identify the role of a lead supervisory authority

Lecture 4:

Co-operation and consistency

Identify the tasks of the European Data Protection Board (EDPB)
Identify how the EDPB ensures consistency of application of the GDPR across the Member States

Speaker

Vanessa Cozens

CEO, The GDPR Clinic

A Chartered Global Management Accountant (CGMA), Vanessa has many years experience working as a financial controller for multi-national businesses.

A holder of the EU GDPR Practitioner (EU GDPR P) qualification which is ISO 17024 accredited and issued by the International Board for IT Governance Qualifications (IBITGQ), she now works with businesses to help them with GDPR compliance and training.

She has vast experience working within senior management teams and has been involved with the establishment and implementation of corporate policies, ensuring that they meet the strict levels of both internal and external corporate standards.

Vanessa is now the CEO of The GDPR Clinic based in the UK and works with businesses to help them with GDPR compliance and training.

Location: London, UK Date: September 12th & 13th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: WILL BE ANNOUNCED SOON

Price:

Price: $1,695.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,695.00 From August 11 to September 10, Regular Price: $1,895.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

Registration Link -http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901168SEMINAR?doctorshangout-September-2017-SEO

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FDA's Software Monsters Cybersecurity, Interoperability, Mobile Apps 2017

2017-07-20T06:18:25.340Z

Course "FDA's Software Monsters: Cybersecurity, Interoperability, Mobile Apps and Home Use" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Software's level of complexity and use is expanding at exponential levels. Likewise, the potential risks to health follow suit. Ransomeware attacks hold your software hostage until you pay hundreds or thousands of dollars. Life supporting and life sustaining healthcare grinds to a halt. Extracting personal healthcare information is another plague that has a huge financial incentive for hackers. Your software is running on thin ice.

The FDA looks at software in one of three ways: Standalone, such as for a mobile app; device-based software used to control a device's performance, or simply electronic records. FDA's risk classification will gradually clarify how it intends to manage the health risks with premarket and postmarket controls. What the FDA did not see was the cancer of cybersecurity attacks, the failure of interoperability, and the explosion in the use of wireless communication and mobile apps.

Inadequate cybersecurity programs and the lack of interoperability for healthcare users pose the greatest threat to any healthcare system. Software exploitations are using more sophisticated approaches and the hackers' programs are readily available on the "dark web."

The increasing sophistication required to protect software programs and have them work with other programs requires progressive software design and software validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. FDA can ask you what you have considered before you take a product to market. Whether your software can survive unscathed is another question. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems, preventing them from recurring. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful of the unknowns that lurk in the future of software regulated as a device by the FDA.

Why you should attend:

For decades, firms have experienced serious problems with software and have been at a loss to make a well-informed follow up. Software problems represent one of the most common root causes for recalls that are associated with deaths and serious injuries beyond what should be necessary to quantify. FDA sees firms revise software only to create more problems rather than solve them. The infusion pump industry is a classic example that drove FDA to implement a new rigorous paradigm for premarket review and performance criteria evaluation.

The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances, clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight of cybersecurity management.

Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability problems surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

These are the kinds of issues that will be highlighted during the webinar. The issues require careful consideration even though no obvious answer appears at hand.

Topics:

FDA's risk-based regulatory strategy
Cybersecurity
Interoperability
National Institute of Standards and Technology
Voluntary standards and programs
Mobile Apps
Premarket software validation and design requirements
Postmarket Software recalls

Who Will Benefit:

Regulatory Affairs
Quality Assurance
Software Design Engineers
Manufacturing
Complaint Dept.
Hospital Risk Dept.
Own label marketers

Agenda:

Day 1 Schedule

9:00 am - 10:15 am

Lecture 1: FDA authority and regulatory program

Types of Software are devices
Regulatory strategy
Risk classification
Office of the National Coordinator (ONC) for Health Information Protection
Software regulatory applications
FDA Guidance
- Premarket submissions
- Paradigms: aeronautics

10:15am - 10:30am Break

10:30 am - 12:00 am

Quality System Regulation (QSR)
- Design verification and validation
- Voluntary standards
- Corrective and Prevent Action Plans
Voluntary standards
Recalls:
- Service / maintenance / recall.
- Implementation strategy
Corrections and Removals reporting
Updates: FDA vs. non-FDA
Predictive analytics

12:00 PM - 1:00 PM Lunch

1:00 PM - 2:30 PM

Lecture 2: Interoperability

Compatibility by design
- Hardware
- Software
Labeling
- Precautions
- Instructions for use
Use of Voluntary Standards

2:30 PM - 2:45 PM Break

2:45 PM - 4:15 PM

Proprietary information
Failure management / follow up
User's vs. manufacturer's legal responsibility
- System configuration
- Customization
- Environment of use
- Professional

Day 2 Schedule

9:00 am - 10:15 am

Lecture 1: Cybersecurity

Device vulnerabilities: malfunction and failure
Pre-emptive design and evolution
Hackers' malware/virus strategy

10:30 am - 10:45 am Break

10:45 am - 12:00 pm

Post-event management
- Corrective and preventive action for software
- Disclosure to users
- Reports to the FDA waiver
National Institute of Standards and Technology Reports

12:00 PM - 1:00 PM Lunch

1:00 PM - 2:30 PM

Lecture 2: Medical Mobile Applications (mobile apps)

Mobile apps defined as a device
FDA regulatory strategy and guidance
National Institute of Science and Technology Report and Collaboration
Updates (FDA vs. non-FDA updates)
- Criteria for corrective and preventive action deemed recalls
- Reports of Corrections and Removals
- Reports of adverse events

2:30 PM - 2:45 PM Break

2:45 PM - 4:30 PM

Lecture 3: Professional vs. lay use / home use

Labeling: instructions for use and precautions
Environment of use
FDA regulation of accessories
Federal Communications Commission (FCC) regulation

Speaker

Casper Uldriks

ex-FDA Expert and former Associate Center Director of CDRH

Casper (Cap) Uldriks brings over 32 years of experience from the FDA. He specializes in the FDA's medical device program as a field investigator, served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. He developed enforcement actions and participated in the implementation of new statutory requirements. He is recognized as an exceptional and energetic speaker. His comments are candid, straightforward and of practical value. He understands how FDA thinks, operates and where it is headed. Cap is the President of Encore Insight, LLC, a consulting service for FDA matters.

Location: SFO, CA Date: September 7th & 8th, 2017 and Time: 9:00 AM to 4:30 PM

Venue: Hilton San Francisco Airport Bayfront 600 Airport Blvd, Burlingame, CA 94010

Price:

Price: $1,295.00 (Seminar Fee for One Delegate)

Until July 20, Early Bird Price: $1,295.00 From July 21 to September 05, Regular Price: $1,495.00

Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

Toll free: +1-800-447-9407

Phone: +1-510-584-9661