Overview
What are the basics of a Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001.
ISO 9001 is an international standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide. It emphasizes the key principles that should be emphasized and those areas to be avoided, based on regulatory inspection / audit findings. It will discuss the key parts of ISO 9001, especially how it applies to manufacturing, but with application suitable for many different business activities, not just manufacturing. ISO 9001 is the underpinning for pharmaceuticals manufacting 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).
Why Should You Attend
"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:
- Systems, Personnel
- Buildings and Equipment
- Documentation and Records
- Materials Management
- Production and Laboratory
- Validation
- Material Rejections / Reuse
- Post-production Issues
Webinar Takeaway
- The Basis QMS - ISO 9001
- A QMS overview
- Systems, Personnel, the Physical Plant
- If it isn't documented, it didn't Happen
- Control of material, product, manufacturing
- Laboratory Controls
- Validations
- Material /product rejection, release
- Complaint handling and other post-production issues
Who Will Benefit
- Senior management in business / industry
- QA / RA
- R&D
- Engineering
- Production
- Operations
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Marketing
Faculty John E. Lincoln
Principal of J. E. Lincoln and Associates LLC
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 of which are as an independent 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis.
