Auditing and Compliance of Biopharmaceutical API Facilities

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 review the fundamental aspects of auditing biopharmaceutical API facilities to ensure their compliance with current regulatory guidelines. Employees who can benefit include:

• Senior Operations and Quality Management
• QA directors and managers
• Production management, supervisors and operators
• Regulatory and Compliance Management
• Laboratory management and analysts
• Quality system auditors

Instructor Profile:

Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and startup companies with the essential advice they need to keep their businesses running efficiently and within regulatory guidelines. With over 30 years of pharmaceutical business, manufacturing and laboratory experience he is an authority on FDA Warning Letters and 483s, GMP compliance, validation planning, outsourcing, microbiology, sterile and non-sterile manufacturing issues. His accomplishments in science (setting up and running laboratories), compliance (auditing, validation, and outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique over site of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.

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