This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
This training session will provide an understanding of the regulations guiding the sterility testing program and the process of conducting an effective, robust and compliant sterility test investigation for various types of sterile products. Attendees will gain an understanding of:
The content of a sterility test investigation form to provide robustness to an investigational process will be shared with the attendees as a tool that may be used when designing a sterility failure investigation program.Learning Objectives:
Module#1 (Requirements of a Sterility Testing Program and Initial Consideration during a Sterility Failure Investigation)
Module#2 (Step by Step Process of Conducting an Effective, Robust and Compliant Sterility Test Failure Investigation)
Module#3 (Effective a Robust Corrective Actions, Preventative Actions, Sample of Investigation Forms, Product Disposition Process and Avoiding Common Mistakes)
This webinar will provide a great resource to personnel involved within the following departments in the pharmaceutical, biotechnology, diagnostics, drugs, cell therapy, biologics, raw material, excipients, chemicals and API suppliers, and medical device industries:
Director of Quality Control, Pharmabiodevice Consulting LLC
Charity Ogunsanya has over 26 years of extensive experience within the Pharmaceutical, Biotechnology, Biologics, Cell-Therapy, Diagnostics, Research and Development, Radio-pharmaceutical, Contract Manufacturing Organization (CMO) and Medical Device companies.
Throughout her corporate career within these diverse industries, she held various high visibility and business critical roles within the Quality and Compliance division in major Fortune 100 companies both as a Subject Matter Expert (SME), Site Manager, Multi-site Manager and Director Levels receptively. She has been a sought after expert and have been consistently hired after several competitive efforts by major fortune 100 companies to assume key roles specifically related to remediation and difficult Quality and Compliance related deficiencies associated with FDA’s Consent Decree, FDA’s Warning Letters and difficult regulatory bodies inspectional findings which is always achieved with a successful outcome. She has also been a sought after expert by various companies requesting her expertise as a known industry expert to specifically assume roles in order to perform a total overhaul, restructure, compliance remediation, re-organization, start-up processes related to Quality Systems improvements and/or enhancements. In all cases, her remediation work resulted in several successful National and International regulatory bodies’ inspections, re-inspection and new product approvals.
Her technical expertise are not limited to the interpretation, administration and set up of Quality Assurance, Quality/Compliance, Quality Engineering, Aseptic Processing, Contamination Control, Quality Control, Microbiology, Sterility Assurance, Stability, Vaccine Development, New Product Design, Product Release Testing and Medical Device Sterilization (Ethylene Oxide (EtO), Gamma, Radiation, VHP sterilization) systems and operations for compliance to various regulations.
Ms. Ogunsanya is vast in the requirements and regulations guiding new and existing products from planning through design, proof of concept, research and development, technology transfer, pre-clinical, clinical, commercial manufacturing, supply chain, regulatory filings, pre-approval inspections, licensure, government affairs, commercialization and post-approval inspections. Her expertise has been sought after by several Fortune 100 Pharmaceutical, Biotechnology, Biologics and Medical Device companies as a Quality and Compliance SME during critical national and international regulatory bodies’ routine and new product approval inspections.
She is the CEO of Pharmabiodevice Consulting LLC (www.pharmabiodeviceconsultant.com) targeted towards Quality and Compliance related remediation, enhancements and consultant services for various companies within the industry. She is a well sought after high level consultant for several international professional expert networks such as Gerson Lehrman Group, Zintro Expert Network and Intota Expert Network. She is a member of the Parenteral Drug Association (PDA), American Society of Microbiologists (ASM), and other Scientific Forums and Industry Expert Network.
Performing an effective, robust, complete and compliant sterility test result failure investigation is an effective tool that helps to prevent future loss of product, regulatory filed complaint and product recalls. Further contamination of subsequently manufactured batches of finished products, raw materials, bulk drug substance or excipient may be prevented if the source of the contaminant is clearly identified at the onset of the initial sterility test failure investigation using an effective and compliant investigational process or tool.
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. FDATrainingAlert 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.
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