This training program will provide regulatory requirements (US) of 21 CFR 111 for Dietary Supplements, 210/211 for Drugs, 820 for Medical Devices, and 4 for Combination Products, and will illustrate the key issues with examples. It will furnish details on what raw materials management from specification, purchasing, receipt, QC, storage, manufacturing, finished goods, and final QA quality management systems are mandated to address.
Why Should You Attend?
The control of raw materials (RM), as well as components and sub-assemblies is an important element of the CGMPs for all regulated industries. This includes acceptable materials and non-conforming materials, their separation, disposition, resolution and handling. Manufacturers are required to manage carefully their entire supply chain, internally as well as externally. The FDA focuses on how companies are addressing such systems and procedures and their functional implementation.
This subject touches on most of the basic CGMP concerns and requirements for industries as raw material is followed from design control call out and selection, to specification generation, sourcing and purchasing, receipt and initial QC inspection, routing / handling, storage, issuance, consumption in the manufacturing process, further QC inspections (WIP), resulting in the finished product and final QA . The role of risk-management tools such as ISO 14971 and ICH Q9 play in decision making and implementation of CGMP-compliant RM systems. Post-production issues will be also discussed. The webinar includes a challenges and conclusion session as well.
Areas Covered in the Webinar:
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 29 years experience in U.S. FDA-regulated industries. 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