Why Should You Attend:
FDA inspectional findings (form 483’s), warning letters, product recalls and plant shut down (voluntary or involuntary) relating to incomplete, ineffective and non-compliant OOS investigations impacts a manufactured product. Failure, Deviation or OOS results investigations regardless of its impact must be adequately documented, analyzed for root cause with a justifiable retest plan and planned corrective action plan. The result of an OOS investigation impacts the quality of the cGMP manufactured product and its labeled claim to avoid it from being tagged as ‘adulterated” which may potentially lead to a product recall, complaint and further actions by the FDA. Understanding how to identify a true OOS from an invalid assay, performing a retest based on the findings of the OOS investigation, when and how to use “averaging” of a test and re-test result versus an “outlier” is critical in the achievement of regulatory compliance.
This 90-minute training will benefit manufacturers of cGMP products in designing an effective, robust and compliant OOS investigation process.
This webinar will provide the attendee the following skills:
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will provide a great resource to Pharmaceutical, Biotechnology, Biologics, Drugs, Medical Device, In-vitro Diagnostics Industry personnel within the following functions:
Charity Ogunsanya has more than 23 years of extensive experience within the Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries and has been the Microbiology, Sterility Assurance, Contamination Control, Aseptic processing, Quality Control Subject Matter Expert (SME) for multiple fortune 100 companies. She has a Bachelor of Science degree in Microbiology from the University of Benin-Nigeria and is currently in the Advanced Academic Master’s Biotechnology Program at the Johns Hopkins University with concentration in Biotechnology/Biodefense. She is the CEO/Owner of her consulting firm named Pharmabiodevice Consulting LLC. Her consultancy provides support to Biologics, Pharmaceuticals, Radiopharmaceuticals, Biotechnology and Medical Device Industries.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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