This Biopharmaceutical training will introduce and link the concepts of GEP and QbD and also identify synergies with the new ASTM E2500 standard Biopharmaceutical Active Pharmaceutical Ingredients (APIs) must be produced according to Good Manufacturing Practices outlined in FDA and ICH guidelines in order to be marketed to the public. This webinar will review the areas that an inspector may examine when conducting an audit of a biopharmaceutical API supplier to ensure it complies with regulatory requirements.
Areas Covered in the seminar:
- Review of applicable regulatory guidelines that oversee the manufacturing of Biopharmaceutical APIs.
- What are the GMP requirements I need to know?
- What are the specific guidelines for APIs manufactured by cell culture/fermentation?
- What are the requirements for cell bank maintainence and record keeping?
- What are the requirements for cell culture/fermentation?
- What are the requirements for harvesting, isolation and purification?
- What are the requirements for viral removal/inactivation steps?
Who Will Benefit:
This webinar will benefit project teams that are facing new capital projects that must focus on meeting FDA scrutiny for meeting qualification and validation expectations.- End users
- Engineering service providers
- QA personnel
- Regulatory compliance specialists
- Quality system auditors.
- Consultants.
Course Provider
Jeff Odum,
