The Food and Drug Administration (FDA or the Agency) has published a guidance document dedicated to the submission and review of sterility information in the premarket notification (510(k)) submissions for devices labeled as sterile. The document is intended to provide additional clarifications regarding the scope of information to be submitted, as well as recommendations to be considered by medical device manufacturers applying for marketing approval. An alternative approach could be applied, provided such an approach is in line with applicable legislation and has been agreed with the authority in advance.
This course outlines the scope of information to be submitted when applying for marketing approval concerning sterility and pyrogenicity. The course also references the FDA-recognized voluntary consensus standards the manufacturers may use when demonstrating compliance with the applicable regulatory requirements.
Areas Covered:-
Review Supplier Management Regulatory Guidance
Who Will Benefit:-
Any Organization, Institution or Group User can register
Registration Form support@webinaraxis.comDownload the
Order FormAccess Information for Live Session will be emailed to you 12 hours prior the live date.
Access Information for On-Demand, and Transcript will be emailed to you 24 hours post of the live session.
Also, You can access the training information from your dashboard at WebianarAxis.
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes, and cleaning validation.
Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.
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