This Pharmaceutical training will include major items to look for during the audit of an API CMO.
Step by step itemization of key auditing elements of an API facility/operation. This presentation will include major’s item to look for during the audit of an API CMO. For example: selection, designation and documentation of starting materials; considerations for a chemical production facility such as process and material flows; qualification of analytical methods; requirements for intermediates testing, hold steps and release; and control requirements for multi-product/multi-processing API production facility; QA review and release of API; Quality systems; and Supplier qualification.
Areas Covered in the seminar:
- Review and discuss all audit elements for small molecules API facility/CMO.
- Using the FDA Compliance Program Guidance Manual.
- 7356.002F-Process Inspection additional items through our experience and knowledge.
Who will benefit:
This webinar will provide valuable assistance to all personal in the API Pharmaceutical industries. Personnel from the following functional areas will benefit from this course:
- Quality Audit
- Operations
- QA/QC
- Contract Manufacturing
- Regulatory
- Managements
Instructor Profile:
Jamie Jamshidi, CEO/President, has over 21 years of industry experience including Small Molecules and Biological/Protein products. She retired from Amgen Inc. after 17 years of service with the company. She has extensive knowledge and expertise in the areas of Quality Assurance, Manufacturing/Operations, Validations, Analytical Laboratories, Regulatory Submissions, Regulatory Inspections (PAI), Project Management, and Managing Contract Manufacturing sites, Technology Transfer, Management and Team Leadership including a broad understanding of the entire drug development process. She has extensive knowledge of FDA, EP, and JP regulations, ICH guidelines, and Qualified Person (QP) requirements under EU Directives.
