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Boot Camp on the Quality Management System (QMS) – Per ISO and US FDA’s GMPs
This seminar 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:
- QM Systems
- Personnel
- Buildings and Equipment
- Documentation and Records
- Materials Management
- Production and Laboratory
- Validation
- Material Rejections / Reuse
- Documentation Requirements
- Post-production Issues
- Self and Supplier Audits
Overview of the webinar
This 3-hour seminar is focused on the workings of the Quality Management System, what is required of a compliant system according to ISO 9001, and the QMS audit. This seminar 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).
Who should attend?
- Senior management in Devices, Pharma, Combination Products
- QA / RA
- Medical products development and testing teams
- R&D
- Engineering
- Production
- Operations
- Marketing
- Consultants; others tasked with medical product development, manufacturing, logistics and V&V responsibilities
Why should you attend?
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. ISO 9001's principles are 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). Further emphasis on QMS principles will be discussed by evaluating the conduct of a regulatory audit, and the major areas to address.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 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 including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. 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 ptublished 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.