This webinar will discuss in detail key auditing elements of an Active Pharmaceutical Ingredient (API) facility/operation. It will cover selection, designation and documentation of starting materials; qualification of analytical methods; control requirements for multi-product/multi-processing API production facility; QA review and release of API and much more.
Why Should You Attend:
This webinar will detail step by step itemization of key auditing elements of an API facility/operation. It 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 Webinar:
- Review and discuss all audit elements for small molecules API facility/CMO.
- Using the FDA Compliance Program Guidance Manual.
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
Course Provider
Jamie Jamshidi,
