Microbiology Training Course
For products that claim a desired Sterility Assurance Level (SAL), proof of a defined SAL (specification) is achieved through the product’s sterilization and sterility assurance controls. Compliance Observations cited each year by the FDA on Form 483s that relates to Sterilization and Sterility Assurance processes shows that there are deficiencies associated with these key processes that are critical to a product’s sterility including inappropriately qualified and trained personnel required as key staff to implement a fully compliant sterilization process.
This online training will benefit professionals working in the Pharmaceutical, Biotechnology, Drug, Biologics, Medical Device, Compounding Pharmacies, and In-vitro Diagnostics Product Manufacturing industries. It will be especially valuable for personnel and management within the following areas:
- Sterilization Engineers and Specialists; Microbiologists
- Sterility Assurance Auditors; Quality Assurance Supplier Auditors
- Quality Assurance: Quality Control
- Laboratory; Testing Analysts and Technicians
- Materials Management
- Suppliers and Vendors of Pharmaceutical Gas Systems
- Validation
- Regulatory Affairs
- Manufacturing
- Shipping; Receiving
- Facility
- Maintenance
- Engineering
This can potentially lead to Product Failures (Sterility Failures), product Non-conformances, Product Recalls, FDA’s Warning Letters, Consent Decrees and discontinuance of commercial operations which may negatively impacts a company’s profitability. FDA regulated industries that produce products with a defined SAL are obligated to have adequately trained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidance with the impacted systems.
This accredited training introduces both new and existing employees to the basics of Microbiology with emphasis on the history, various microbiological era’s and specific discoveries within each Era. Attendees will gain full knowledge of the detailed study, principles and characteristics of microorganisms and how they relate to cleanroom contamination, asepsis and infection including its applicability in product manufacturing activities. This course will describe the various types of disinfection and sterilization processes as well as the impact on contamination control within the manufacturing cleanrooms.
Upon completion of this course, you will be able to:
- Describe the history, various Microbiology Era’s and specific discoveries within each Era
- Summarize the detailed study and principles of microbiology
- List the characteristics of the major groups of microorganisms
- Describe causes of asepsis and its relationship with the infection process
- List the various aspects of disinfection and sterilization and its impact on contamination and infection control processes