Installation and Qualification of the Packaging Lines

Description:

Review a company's Installation and Qualification / Process Verification and Validation system for device and pharmaceutical packaging systems, methods, equipment, control of and testing for best practices as well as major cGMP deficiencies.

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. Develop the Qualification Plan, including the requirements for equipment / process DQs, IQs, OQs, and PQs, or their equivalents. The field-tested examples address the key ares of packaging process and equipment, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 and cybersecurity issues as needed are explained.

Why Should You Attend:

Inspections of company packaging lines and their validation / qualification show major cGMP deficiencies. List as the instructor shares his experience as a manufacturing engineer who set up new production and packaging lines, and as a QAE and QA Director and Consultant who inspected them for CGMP compliance. Acceptable approaches and common mistakes. What is risk-based process V&V planning / execution. The "must have" elements from the CGMPs, ICH Q&, as well as how ISO 14971( and ICH Q9) for hazard analysis and product / process risk management fit in. Integration of the packaging line's equipment and process validation essentials into a company's overall quality management system.

Areas Covered in the Webinar:

Participants will learn how an effective packaging installation and qualification is planned, executed, and documented. Also how it is effectively based n the critical requirement of a risk-based approach to compliance and personnel and product safety.

• Assurance of personnel and user safety and product quality from CGMP compliant validation

• Packaging line issues: Devices and pharmaceuticals

• Equipment and process validations and best practices
• Understand the scope of regulations governing packaging line qualification / validation and identify gaps
• Develop a plan to rectify existing validation plans, protocols and reports
• Develop and implement the Validation Master Plan

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that need to review and modify their packaging lines, their installation or modification, and their qualification and proper execution / documentation. Geared to all FDA- regulated industries (and EU and Asia) The employees who will benefit include:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• Engineering, including Software
• All personnel involved in qualification, verification and/or validation planning, execution and documentation.

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 42 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with global companies to resolve regulatory issues, lead validations (hardware and software) and implement QMS/RA systems. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on Validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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