ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems and is used as such by companies worldwide.
This instructor-led live training webinar will discuss the key parts of ISO 9001, especially how it applies to manufacturing. However, its principles can, and are, used in many different business activities, not just manufacturing. ISO 9001 is the underpinning for pharmaceutical manufacturing worldwide, with its principles incorporated in the US CGMPs (Good Manufacturing Practices) for pharma, 21 CFR 210 and -211 (actually the other way around), and in ICH Q7, GMPs for APIs (Active Pharmaceutical Ingredients).
This webinar will evaluate the requirements for the foundational / basic Quality Management System (QMS), ISO 9001m and how most QMS' requirements build upon that foundation. Then it will go into a detailed analysis of the basic requirements of ISO 9001 and what that means for the typical manufacturing company (and others). Subject areas considered are:
The following individuals or disciplines will benefit from attending this Webinar:
John E. Lincoln is the Principal of J. E. Lincoln and Associates, a consulting company with over 41 years of experience in U.S. FDA-regulated industries, 27 of which as head of his own consulting company. John has worked with companies from start-ups 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, FDA responses, new/changed product 510(k)s, process/product/equipment incl+D33uding QMS and software validations, ISO 14971 product risk management files/reports, Design Control / Design History Files, Technical Files. He's held Manufacturing Engineering, QA, QAE, and Regulatory Affairs positions at the Director and VP (R&D) levels. In addition, John has prior experience in the military, government, electronics, and aerospace. He has published numerous articles in peer-reviewed journals, including 5 chapters in the RAPs validation textbook, and conducted workshops and webinars worldwide on regulatory issues. John is a graduate of UCLA.