General Principles of Process Validation for Drugs and Biologics
Date: December 18, 2024
Duration: 60 Minutes
Time: 12 PM EST
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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
