Overview

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 webinar discusses 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).

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

  • Basic QMS Principles
  • Systems, Personell, 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
  • Marketing
  • Consultants
  • Others Tasked with Pharmaceutical Development, Manufacturing, logistics and V&V Responsibilities

Faculty John E. Lincoln

Medical Devices / Regulatory Consultant; also pharma and dietary supplements

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and 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).

1.5 RAC CREDITS

RAPS - This course has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria

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