GMPs for All Phases - Ensuring GMP Compliance - 2-Day In-Person Seminar by Ex-FDA Official
Duration : 2 Days
Peggy J Berry,
Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, Read more
Good Manufacturing Practices are the foundation for all drug & biologic products intended to be dosed to humans. Sponsors are legally required to follow GMPs in their manufacturing processes. It’s recognized that early clinical trials involve a small number of subjects and require a small amount of product. And, at this early stage, could present undue investment burden for sponsors to comply fully with all GMPs. Therefore, provisions have been made to use a risk-based approach across phases of development. This workshop will provide details for you to ensure GMP compliance.
Who Will Benefit:
• Directors
• Manager
• Supervisors
• Lead workers in Regulatory Affairs Quality Assurance and Quality Control
• Personnel who will prepare GMP documents
• Personnel who will review GMP documents
What You Get:
• Learning Workbook
• USB drive of reference materials
• Lunch and Refreshments
• Participation Certificate
• Gift Certificate for $100 for next Seminar
Location:
Boston
Venue will be announced soon.
DAY 1:
- Registration
- Core principles of GMP Regulatory requirements across phases
- Raw material requirements and process development
- Quality Assurance Required
- SOPs
- Batch records
- Practical exercise: Complete a batch record and perform quality control
- Manufacturing process development & scale-up
- Method development
- Qualification vs. Validation
- Discussion & Review: Qualification vs. Validation
- Validation Requirements across regions & phases of study
- Vendor selection & management
- Practical exercise: Assess vendor qualification & develop quality agreement
DAY 2:
- Vendor Management & Oversight
- Training Requirements
- SOP Development & Evolution
- Practical Exercise: Compare SOPs using a CMO vs. internal activity
- Quality & Manufacturing Content Requirements for the IND/CTA/INDS- in CTD format
- Practical exercise: Building CTD content for Module 3
- Life cycle management considerations; document granularity
- Considerations for Setting specifications and expiring/re-test dates
- Practical exercise: Set specs for phase 1 study material
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
