This Microbiology training/webinar will provide a new approach in ensuring the Microbiological Integrity of Pharmaceutical and Biopharmaceutical Facilities.
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.
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
Course Provider
Frank Settineri,
