This webinar is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of finished pharmaceuticals under an appropriate system for managing quality. It is also intended to help ensure that The final drug product meets the quality and purity characteristics that they purport, or are represented, to possess.
This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS) and how CGMP requirements further define the specifics and their implementation and documentation. The Drug CGMPs are similar to all CGMPs, but have many enhanced or unique requirements which will be highlighte in this presentation. Subject areas considered are:
21 CFR 210 and 211 is US law for mandateded Good Manufacturing Practices for finished pharmalogical products. When a drug product is intended to be marketed in the US, it must be manufactured under the requirments of the CGMPs, 21 CFR 210 / 211. This webinar discusses the key parts of the CGMPs that applies to the manufacture of drug for use in humans. The sterilization and aseptic processing of drugs should also be performed in accordance with the CGMPs. Failure to conform and document to the CGMPs will result in Warning Letters and further remedial actions from the US FDA.
Areas Covered in the Webinar:
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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