Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

Pharmaceutical and biopharmaceutical companies must operate under cGMPs as described in the predicate regulations, 21CFR210 and 21CFR211, in order to sell their products to the public. A forgotten aspect of GMPs is that they were written to prevent contamination of products. Therefore, the microbiological wellness of a facility is a critical attribute that auditors examine to determine whether or not a facility is cGMP compliant. This webinar will outline actions to take to ensure the microbiological wellness of your facility and will introduce the concept of "Thinking like a Bug" that will help your company operate in a manner which prevents and eliminates microbial excursions, enabling you to comply with cGMPs and also save money.

Areas Covered in the seminar:

• Overview of Microbiological Wellness and Thinking Like a Bug.
• Why should I Think Like a Bug?
• How do I Think Like a Bug?
• How does Thinking Like a Bug help me become cGMP compliant?
• How do I apply the concept to the regulations?
• Specific actions to take on various sections of the regulations.
• How can I save money by Thinking Like a Bug?

Who will benefit:

This webinar will provide a new approach to meeting cGMP requirements that will allow a company to reduce microbial excursions, thereby allowing it to save money by holding or rejecting fewer products, not having to buy expensive, cumbersome equipment and making everyone accountable for their actions. Employees who can benefit include:

• Senior Management responsible for making final decisions
• QA directors and managers
• Microbiology analysts and technicians
• Regulatory and Compliance Management
• Consultants
• 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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