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Process Validation for Drugs and Biologics

 
  December 06, 2006  
     
 
The Center for Professional Innovation & Education (CfPIE), Malvern, PA
Feb. 15 & 16, 2007


Who Should Attend

Attendance will be beneficial to personnel directly involved in process validation as well as beginning or seasoned operational personnel who will eventually participate in such efforts. Individuals in management who interact with the above or interact with regulatory agency inspectors to rationalize or defend validation programs will also benefit from attending this course. There are no particular requirements for this course, but a basic knowledge in general science and processes is helpful.

Learning Objectives

By the end of the 2-day course you will …

• Understand the importance and underlying principles of process validation
• Be able to set up process validation protocols and reports that meet current FDA and EMEA regulations
• Prepare and defend your own process validation approach and program
• Avoid costly delays and rejections by regulatory agencies due to weaknesses in existing process validation programs, as well as, those prepared and executed by a third party and/or contract validation companies

Course Description

Process validation is not a curse, invented by regulators, pushed onto a company by QA staff. Process validation is a legal requirement in the pharmaceutical industry. Regulatory agencies will not approve your product without it. The concept of process validation is recognition that quality cannot be tested into the product.

In most cases, a branch within the “Quality” organization of the firm handles coordinating and documenting compliance with this requirement, and the concept still evokes undertones of mystery and the unknown to some engineers and scientists from other disciplines within “Operations”. However, the fact is that operational personnel will most likely have to interact with the group responsible for the execution of the process validation efforts sooner or later. This course provides practical guidance on compliance with the requirements of process validation that leads to risk-based, reasonable and supportable informed decisions and planned activities. Compliance with the requirement for process validation must go hand in hand with sound science for the proper evolution of critical processes.

The course includes process validation examples from sterilization, biologic and biopharmaceutical manufacturing processes.

________________________________________

COURSE AGENDA

DAY ONE

 Historical overview of the validation of pharmaceutical processes

- Deficient process validation: a public safety issue
- Cost of non-compliant process validation

 General regulatory guidance on process validation

- Validation terminology defined: key to communication
- The 3 approaches to process validation
- Process validation should lead to less release testing!

 Process validation building blocks

- Critical importance of corporate commitment to validation
- The Validation Master Plan (VMP)
- Qualification: DQ/IQ/OQ/PQ

 Pharmaceutical process validation lifecycle

- The pharmaceutical development regulatory process
- Process validation during clinical trial phases 1, 2, 3?
- Process validation for and after market approval

DAY TWO

 Effective process validation

- Total process validation – from initiation through maintenance
- Eight key steps for successful process validation

 Practice on specific pharmaceutical process validation protocols

- Practice, practice, practice – developing process validation protocols for aseptic drug processing, cleaning validation, terminal moist heat sterilization, biologic/biotechnological chromatography processes

 Current FDA concerns about validation of pharmaceutical processes

- Process validation deficiencies observed by the regulatory inspectors, as reported in Establishment Inspection Reports (EIRs) and FDA 483 observations!

 The future of process validation

- Potential impact of Process Analytical Technology (PAT)

 
 
Organized by: Center for Professional Innovation & Education
Invited Speakers: Please contact The Center for Professional Innovation & Education at info@cfpie.com or call +1-610-688-1708 for Speaker information.

 
Deadline for Abstracts: n/a
 
Registration: To register, please visit www.cfpie.com or call +1-610-688-1708.
E-mail: info@cfpie.com
 
   
 
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