Friday, January 16 9–11 AM PST | 12–2 PM EST
Master Manufacturing and Batch Production Records Regulatory Expectations, Execution, & Compliance
Live Virtual Webinar Speaker: Gary Pecic National Expert Dietary Supplements, FDA
Event Overview This virtual webinar will provide a comprehensive overview of Master Manufacturing Records and Batch Production Records, including their creation, execution, shared elements, and Quality Control responsibilities. The webinar will include a detailed discussion of in-process specifications, material reviews, verifier requirements, maintenance and sanitation documentation, and the distinctions between rework and reprocessing. Participants will also gain clarity on electronic batch record compliance requirements and the proper documentation of manufacturing, in-process steps through finished product release.
What You’ll Learn During this webinar, participants will gain practical insight into:
- Understanding the regulatory compliance requirements of Master Manufacturing Records and Batch Production Records
- Required elements of MMRs and BPRs and how they align
- Quality Control responsibilities related to record review and approval
- In-process specifications and documentation requirements
- Material review processes and verifier requirements
- Maintenance and sanitation documentation expectations
- Key differences between rework and reprocessing
- Electronic batch record compliance considerations
- Proper documentation from manufacturing and in-process steps through finished product release
Who Should Attend This webinar is ideal for professionals involved in:
- Manufacturing operations
- Quality Assurance and Quality Control
- Regulatory Affairs
- Compliance and auditing
- Dietary supplement and regulated product manufacturing
Why Attend
- Learn directly from an FDA subject matter expert
- Improve inspection readiness and documentation accuracy
- Reduce compliance risk related to manufacturing records
- Gain clarity on regulatory expectations and best practice
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