Webinars>>​Process Validation (FDA Regulation and Compliance)
GMP Process Validation for Early Stage Clinical Material: 3 steps to Compliance

FDA’s first guidance on process validation was released almost 25 years ago. Since then manufacturing technology has come a long way and so has the diversity in the products, technologies and processes used in the manufacture of drugs and biologics. To address this change, FDA released a new guidance in 2011 to address modern process validation methods. This guidance works in conjunction with several other guidance documents that address quality system and quality management practices. This webinar will provide a brief introduction to the history and a detailed analysis of the currently acceptable practices using case studies and examples.
Why should you attend:

The most common CMC deficiency indentified by FDA reviewers is inadequate process validation. A manufacturer needs to establish by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. Validation of all processes involved in manufacture of drug and biologics is essential for meeting FDA’s Good Manufacturing Practices (GMP) requirements. Process validation is considered as the first step in process development for manufacturing biopharmaceuticals. This webinar will discuss the latest guidance from FDA regarding process validation. The 60 minute webinar would summarize the FDA-acceptable 3-step method that can be used for process validation of most manufacturing and testing methods. Attendees will be able to evaluate process validation reports.
This seminar will discuss practical strategies for process validation that can be generally applied to all processes for manufacture or testing of drugs and biologics. Key strategic considerations will be discussed using real-life case studies. At the end of the webinar, attendees will be able to evaluate validation requirements for any given process, the documentation requirements, and the audit issues with regards to FDA acceptability of the same.
Topics Covered in the Session:
  • FDA's intent from process validation requirements
  • Evaluating processes that need formal validation reports
  • Evaluating critical and non-critical process parameters
  • General considerations for process validation
  • Process design, qualification and verification
  • Concurrent and retrospective validation
  • Process validation reports
  • Documentation requirements: Process validation reports
  • Validation verses verification: Which processes need formal validation reports
  • Common errors and suggested remedies
Who will benefit:

​This webinar will provide valuable assistance to all personnel in:
  • Regulatory affairs professionals
  • Personnel in development, manufacturing, and QC testing
  • Project managers
  • CMC writers and technical writers
  • Regulatory Compliance Associates and Managers
  • People investing in FDA-regulated product development projects
Date: December 20, 2018
Time: 12 PM ET    Duration: 60 Minutes

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA

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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com