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Cleanroom, Cleaning, Sanitization and Disinfection Practices 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 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 entire process of cleaning and disinfection terminologies, practices, requirements, process steps, types of disinfectants, composition and specific roles in contamination control as it applies to cleanrooms used for manufacturing activities.
The importance of cleaning and disinfection cannot be over emphasized due to its criticality in ensuring a state of contamination control in order to prevent product contamination and potential loss of the products. This webinar will describe in detail a very robust cleaning and disinfection program requirements that can be applied in creating a robust cleaning and disinfection Standard Operating Procedure (SOP). The webinar will also discuss a sample of FDA’s issued form 483s compliance issues associated with cleaning and disinfection deficiencies as well as their resolution.
Upon completion of this course, you will be able to:
- Define terminologies of cleaning, disinfection, and decontamination applicable to cleanroom classifications.
- List the types and classification of different types of Disinfectants, Sanitizers and Sterilizing Chemicals
- Describe the different types of disinfectants, sanitizers and sterilizing chemicals and their applications within product manufacturing cleanrooms
- Define the content of a robust cleaning, sanitization, and disinfection program requirements
- Establish the importance of cGMP Cleanroom Cleaning and Disinfection Chemistries and Frequencies
- Demonstrate the Do’s and Don’ts of cleaning and disinfection based on recent FDA’s Form 483 and Warning Letter compliance citations
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
- Quality Assurance; Quality Control
- Sterility Assurance Auditors; Quality Assurance Supplier Auditors
- Laboratory; Testing Analysts and Technicians
- Manufacturing; Shipping; Receiving; Facility; Maintenance; Engineering
- Validation; Regulatory Affairs
- Suppliers and Vendors of Pharmaceutical Gas Systems
- Materials Management