Ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities
Instructor:
Frank Settineri
Product ID: 701145
Training Level: Intermediate to Advanced
- Duration: 90 Min
Pharmaceuticals and biopharmaceuticals are products that are designed to make people well. Therefore it is incumbent upon manufacturers to ensure these products are manufactured in a manner that ensures their microbiological integrity. Achieving this goal requires a few simple activities: maintaining a clean facility, selecting the right people and training them to be constantly aware of their microbiological footprint. Companies that adhere to these principles will not only be close to being compliant with regulatory requirements but will also promote the health of patients who use their products.
Areas Covered in the seminar:
- Overview of Microbiological Integrity.
- Expectations of cGMPs.
- Microbial Integrity: Cleanliness.
- Microbial Integrity: People.
- Microbial Integrity: Training.
- Microbial Integrity: Compliance.
- Case Studies.
- Specific actions to ensure microbiological integrity.
- Making microbial integrity pay for you.
Who will benefit:
- End-users responsible for applications that need to be validated
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- Quality system auditors
- Consultants
Frank Settineri, is the founder and President of Veracorp LLC, a consulting firm that specializes in providing pharmaceutical, biotech, medical device and start up companies with the essential advice they need to keep their busineses 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, outsourcing) and business (building a start-up pharmaceutical company and its infrastructure) endow him with a unique oversite of the industry that has benefited his clients, including major pharmaceuticals, start ups, laboratories and generic companies.
More Training By Experts
- A Practical Approach to Microbial Data Deviation Investigations
- Practical Aspects of Aseptic Processing
- 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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