Webinars>>​Process Validation (FDA Regulation and Compliance)
General Principles of Process Validation for Drugs and Biologics

FDA's first guideline on process validation was released about 25 years ago. Since then the manufacturing technology has come a long way and so have the diversity of products, technologies and processes used in the manufacture of drugs and biologics. In 2011 FDA released another guidance primarily to address modernization of process validation methods. Several other guidance documents have since been released to describe FDA’s expectations from validated processes for manufacturing drugs and biologics.
Why should you attend:

The most common CMC deficiency identified 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 final step in process development prior to manufacturing biopharmaceuticals for commercial distribution.
 
This webinar will discuss the latest guidance from FDA regarding process validation. Practical strategies for process validation that can be generally applied to all processes for manufacture or testing of drugs and biologics will be discussed. Key strategic considerations will be discussed using real-life case studies. Simplified approaches to process validation based on scientific logic and best practices will be discussed. At the end of the webinar, attendees will be able to evaluate validation requirements for any given process, the documentation requirements with regards to FDA acceptability of the same.
Topics Covered in the Session:
  • What is Process Validation (PV)
  • Practical considerations for PV
  • Approaches to PV
  • Life-Cycle Approach to PV
  • The phases of PV
  • Setting up PV at process development
  • Process design, qualification, and verification
  • Process validation reports
  • Successful PV requirements
Who will benefit:

​This webinar will provide valuable assistance to all personnel in:
  • Personnel in process development and manufacturing operation
  • Regulatory affairs professionals
  • Project managers
  • Quality Control and Quality Assurance professionals
  • People investing in FDA-regulated product development projects
Date: December 1, 2021
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