A Practical Approach to Microbial Data Deviation Investigations
Instructor:
Frank Settineri
Product ID: 701129
Training Level: Intermediate to Advanced
- Duration: 90 Min
Areas Covered in the seminar:
- What guidance documents govern microbiological data deviations (MDD).
- What should we do about the specific batch and related batches of products when an MDD is found?
- What is the difference between an objectionable microorganism and one that is pathogenic?
- How do I determine the root cause?
- How do I conduct a microbiological risk assessment?
- How do I determine a corrective and/or preventative action?
- How to I demonstrate that the corrective/preventive action was effective?
- What can I do to minimize the reappearance of the excursion?
Who will benefit:
This webinar will provide definitive actions to follow when a microbiological data deviation (MDD) is encountered. It will allow the company to properly disposition its affected product(s) and will provide actions designed to prevent future occurrences. 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
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 business 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 oversight of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.
More Training By Experts
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- Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities
- Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
- Auditing and Compliance of Biopharmaceutical API Facilities
- Objectionable Microorganisms: Considering the Risk
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