Live Online Training: FDA's New Process Validation Guidance

Primer on Actions You Need to Begin Taking NOW
 

• Thursday, February 24, 2011
• 10:45 am - 12:00 pm
• Eastern Daylight Savings Time
• United States
• Live Online Training!

Instructor: Eldon Henson, Director API Products and R&D Quality, Covidien (formerly Mallinckrodt). He has 3,000+ hours of direct contact related to FDA investigations, most of which included coverage of process validation. Read his complete biography below...

Live Online Training Content:

• Background on FDA's New Guidance on Process Validation
• Why did FDA upgrade the Guidance on process validation now?
• Alignment with ICH Q8, Q9, and Q10
• Definition and goal of process validation
• Former approach compared to FDA's new approach
• Stage 1 - Process design
• Stage 2 - Process qualification
• Stage 3 - Continued process verification
• New Keys to a successful validation program
• Understand the sources of variation
• Detect the presence and degree of variation
• Understand the impact of variation on the process and product
• Control the variation commensurate with risk
• General considerations for process validation
• Stage 1 - Process Design: Key points and practical applications for:
  • Building and capturing process knowledge and understanding
  • Establishing a strategy for process control
• Stage 2 - Process Qualification: Key points and practical applications for: 
  
  • Design of a facility and qualification of utilities and equipment
  • Process performance qualification (PPQ)
  • PPQ protocol
  • PPQ protocol execution and report
• Stage 3 - Continued Process Verification: Key points and practical applications for:
  
  • Concurrent Release of PPQ Batches
  • Documentation
  • Analytical Methodology
• What is FDA trying to accomplish and what benefits can be expected from this approach to process validation?
• What specific actions do we need to take now?
• Summary, conclusions, and final recommendations

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 Questions and Answers

There will be a 15-minute question and answer period for attendees to submit questions. If we are unable to answer your question due to time constraints, our instructor Eldon Henson will provide an e-mail response after the training concludes.

Who Should Attend

This training is designed for all individuals involved in quality systems, quality control, compliance, regulatory affairs, manufacturing, or other key groups. In short, any individual involved in quality, validation or compliance activities will benefit from this discussion, especially the new direction being taken by FDA regarding the lifecycle approach to process validation. Attending this training will provide a solid overview of how FDA is beginning to apply principles of ICH's Q8, Q9, and Q10 to cGMP compliance.

What You Receive for only $249.00:

Invite as many co-workers as possible for this training. Quality content training for one low price. In addition, you also receive:

➢PDF Powerpoint Training Presentation

➢Webinar Recording (No restrictions to length of time recording may be accessed)

➢Frequently Asked Questions and Answers

➢Auditing Process Validation Checklist

➢Complimentary Process Validation CONTENT Package which includes:

• Introduction to Validation and its Documentation (Reference Article)
• Training Script: Conducting Effective Process Validation for a Packaging Line
• Implementing IQ, OQ, and PQ: Making Popcorn (Reference Article)

Read More on this Complimentary CONTENT Package - click here

➢Free Membership in enKap's FDA Compliance learning community - simply fill out a profile.

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About the Instructor:

Eldon Henson, Director API Products and R & D Quality, Covidien.

He has been in the pharmaceutical industry for over 25 years at a variety of firms representing solid dosage forms, aseptically processed products, liquids, medicinal nutritionals, biopharmaceuticals, APIs, and foods. His experience is primarily in the areas of quality assurance and compliance, though he has considerable experience in manufacturing, quality control, and R&D at companies, such as Novartis, Abbott, Boehringer-Ingelheim, Sigma-Aldrich, and others.

He has 3,000+ hours of direct contact related to FDA investigations, most of which included coverage of process validation. He currently serves as a subject matter expert for enKap. and on the Editorial Advisory Boards of the Journal of Validation Technology and Journal of GXP Compliance. In addition, he also serves on the Board of Directors for the Missouri Valley Chapter of PDA. 

FDA Enforcement of Process Validation is increasing...

Recent Warning Letters excerpts:  

 
“There was no process validation study…” 
Smith & Nephew 
 
“…you had not performed validation of the manufacturing process…” 
Synbiotics 
 
“…nor had you established a process design, a validation plan, or qualification protocols” 
CP Pharmaceuticals
 
“Your firm failed to provide validation protocols that evaluated the impact of the increasing batch size on product quality…Further, your firm uses a “Master Validation Plan” for process validation on all products. Validation must be demonstrated for each product and process.” 
Contract Pharmacal Corp. 
 
“Failure to validate (product) to ensure that devices conform to defined user/patient needs and intended uses, as required by 21 C.F.R. § 820.30(g).”
 
“Failure to establish procedures and to validate a process whose results can not be fully verified by subsequent inspection and test, as required by 21 C.F.R. § 820.75(a).”
OsteoSymbionics 
 
“…your firm failed to perform process validation for three USP products: This is a repeat observation.  The June 2001 FDA inspection reported that your firm failed to conduct process validation studies for (product) a USP product manufactured at your facility. “
 
“Your firm failed to perform stability studies for (product) to support the (product) year expiration date currently assigned.  This is a repeat observation.  The June 2001 FDA inspection documented your failure to perform stability studies on (product), a USP product manufactured at your facility.”
 
“Your firm failed to perform cleaning validation studies to support the use of "city water" to clean all your equipment.” 
Macco Organiques 
 
“Your firm has failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods [21 C.F.R. § 211. 165(e)]. 
 
For example, your firm performed analytical method transfers for 236 protocols without determining whether those methods had been properly validated by your clients.”
Advanced Testing Laboratory 
 
“…your firm has not conducted performance qualification for the unit-dose packaging machine to ensure its proper performance.” 
 
Your “…response is inadequate in that it fails to adequately describe how and on which pieces of equipment qualification will be performed.” 
Shamrock Medical Solutions Group 
 
“…you have not validated the manufacturing processes for the following drug products…” 
Benev Company 
 
“…during the process qualification stage of the process validation for (product) you made equipment and process modifications without adequate change control.” 
IriSys, Inc. 
 
“…we are concerned about the length of time your firm has needed to develop and implement its Validation Prioritization Plan …” 
Hospira 
 
“We disagree with your assessment and we do not consider your process validated. Your investigation report conclusion was based on finished product test results alone, and did not consider in-process testing and analyses.” 
Gilead Sciences

Live Online Training: FDA's New Process Validation Guidance  

Primer on Actions You Need to Begin Taking NOW -

February 24, 2011 

Register TODAY in the enKap store - Click Here