Requirements for Aseptic Techniques and Practices

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 483’s 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 adequatelytrained and knowledgeable staff or Subject Matter Experts (SMEs) within sterilization and sterility assurance to provide applicable regulatory guidancewith the impacted systems.

This 3-hour accredited training introduces both new and existing employees to the basic requirements and steps of proper aseptic practices andsources of contamination within cleanrooms and Quality Control testing environments. This webinar provides preliminary understanding of the basics of microbiology and the requirements of cleaning & disinfection as it relates to contamination control requirements. Participants will be able to apply the 4 Pillars of Aseptic Techniques, Cleanroom Behaviors and Practices within product manufacturing and testing Cleanrooms and Cleanzones.

THIS TRAINING IS PART OF OUR STERILIZATION PROFESSIONAL CERTIFICATION

• To enroll into the complete Sterilization Professional Certification Program CLICK HERE. This program includes 10 specific online courses for $3395.
• To learn more about our certification programs, visit our website at Certifications 

To register for this individual course ONLY, click the Register Now button below.