Why Should You Attend:
The Current Good Manufacturing Practice for Finished Pharmaceuticals regulations of the US Food and Drug Administration require investigations to be conducted per 21 CFR Part §211.192 regulations.
Although this regulation has been in effect since 1978, organizations continue to struggle with the effective conduct and documentation of investigations to meet the expectations of regulatory authorities. An FDA guidance document regarding “Out-of-Specification Investigations” was finalized in 2006, but primarily covers the investigation of “chemistry-based laboratory testing of drugs regulated by the Center for Drug Evaluation and Research (CDER)”.
Establishing an effective system of conducting investigations, to ensure compliance of the five manufacturing systems: production, facilities and equipment, laboratory controls, materials, packaging and labeling and the overarching quality system is an essential requirement for the manufacture and commercialization of all FDA regulated products.
This webinar will discuss five key attributes of an effective cGMP investigation, the role of management, employing quality control tools, CAPA effectiveness checks and Warning Letters associated with cGMP compliance.
Areas Covered in the Seminar:
Attendees will learn
Who Will Benefit:
This webinar will provide information to regulated industry including pharmaceutical, biotechnology, responsible for the manufacture of cGMP products. Those functional roles that would derive the most benefit from this webinar include:
Felicia Ford-Rice, is a Principal Consultant with PAREXEL Consulting, a division of PAREXEL International, specializing in Strategic Compliance. Felicia has over twenty years experience working in Research and Development, Regulatory Affairs and Quality Assurance roles for Academia, the US Government, Vaccine and Pharmaceutical manufacturers. In previous roles she has led the creation of the following quality system elements: deviation/CAPA, investigation, effectiveness checks, management review processes, product disposition/ release, aseptic processing support, change control, product complaints, product recalls, quality agreements, EM trending, APRs, controlled documentation management, internal/external audits, supplier qualification, MRB, CRO/CMO oversight, regulatory authority inspection readiness, anti-counterfeiting communications. Felicia has also trained and directed the GMP, GLP, GCP and regulatory inspection readiness training of multidisciplinary staff, taught graduate courses on Regulatory Affairs and Quality Assurance topics for Northeastern University. She has authored technical reports, co-authored or contributed to abstracts and scientific papers published in peer review journals and presented at scientific symposia. Felicia has also served on the SCDM Editorial Board, and the PDA Annual Meeting Program Planning Committee and currently supports the HBA Membership and Marketing Committees. She is a member of PDA, RAPS, DIA, and HBA and holds a RAC Certification.
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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