Integrating Production Equipment, Processes, Systems and Procedures

Speaker

Instructor: John E Lincoln
Product ID: 706956
Training Level: Intermediate to Advanced

Location
  • Duration: 90 Min
Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.
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Description

Review a company's manufacturing engineering practices and its QMS in the integration of production equipment, processes, systems and procedures, against the US FDA's CGMP and industry best practices and expectations. Incorporate the tools and requirements into well-defined, fully-integrated systems. Address the FDA's newer and tougher regulatory stance, and it's most recent guidance documents for actionable principles. One major failing is lack of sufficient or targeted risk-based V&V planning and associated documentation. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management, allows the development of meaningful product quality-specific process validations. Also the roles of different V&V protocols; the addition of Part 11 and cybersecurity issues and other recent concerns.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in plant manufacturing systems integration. Plant level contamination and other CGMP non-compliances have resulted in recent publicized shut-downs, product shortages, and some patient deaths. One major failing is lack of sufficient or targeted risk-based process / system planning /integration / execution. Consider some basic principles in the FDA's Process Validation Guidance Document for pharma. The "must have" elements from ISO 14971( and ICH Q9) for hazards and product / process risk management. Integration of equipment, process validation, systems planning and execution and usable SOP, all which should be essential to a manufacturing engineering and a company's quality management system.

Areas Covered in the Webinar:

Participants will learn how an effective integration and validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Issues to be covered include:

  • Assurance of product quality from a holistic systems integration CGMP-compliant approach

  • Learn how to improve process system knowledge and understanding
  • Learn methods for developing process systems best practices
  • Understand the scope of regulations governing process development, equipment / systems integration and identify and eliminate gaps
  • Develop a plan to rectify existing development, implementation and maintenance validation plans, protocols and reports

  • Learn how to construct, implement and deploy a supportive Validation Master Plan

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their manufacturing equipment, process /systems and procedure integration planning and execution / documentation. While this information is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

  • Senior management
  • Regulatory Affairs
  • Quality Assurance
  • Production
  • Engineering, especially manufacturing engineering
  • All personnel involved in production processes and systems implementation, validation, planning, execution and documentation.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. 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, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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