This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.
This webinar will evaluate the key requirements of the FDA Drug and Device PMA preapproval inspection and submission program - the review of a company's CGMP system, 21 CFR 210 and 211 (drugs) or 820 (devices) for compliance. The goal of a pre-approval inspection is to ensure the FDA that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug are found adequate to ensure and preserve its identity, strength, quality, and purity, or the device in safety and performance (effectiveness).
Subject areas considered are:
When a drug product is intended to be marketed in the US, it must be manufactured under the requirements of the CGMPs, 21 CFR 210 / 211. Devices are cleared under the 510((k) process for Class II and PMA approval process for Class III. This webinar discusses the FDA program used to approve the NDA, ANDA, or a class III device submission from a company only after their methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or device are found adequate through FDA preapproval inspection to ensure and preserve the proposed product's identity, strength, quality, and purity or safety or performance characteristics. Before submission approval, FDA evaluates the establishments by on-site inspections and/or by establishment file review. That evaluation focuses on several key areas of the CGMPs for pharmaceuticals and devices. This webinar will discuss the FDA's use of their preapproval inspection program and its effect on a company's drug or device submission.
Areas Covered in the Webinar:Participants will learn how an effective packaging installation and qualification is planned, executed, and documented. Also how it is effectively based n the critical requirement of a risk-based approach to compliance and personnel and product safety.
John E LincolnPrincipal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. John is a graduate of UCLA.
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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