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Live Webinar The Challenges of Change Control: Its Implementation and Maintenance

October 26, 2020 @ 8:00 am - 5:00 pm

Live Webinar The Challenges of Change Control: Its Implementation and Maintenance

Distinguished Faculty

Mr. Kenneth Christie

Mr. Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, medical devices, APIs and solid dosage processing equipment, utilities, and systems on a global basis. Mr. Christie also performs vendor/supplier audits, site pre-approval inspections and assists clients with addressing and correcting regulatory observations.

Mr. Christie was the Validation Manager at Parke-Davis’ Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA and European inspectors (EMEA), corporate management and third-party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.

Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie serves as a member of the ISPE Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

He possesses a BS degree in Biology from Shippensburg State University (PA) and an Executive MBA degree from Michigan State.

Course Description

Within the regulated industries of pharmaceuticals, medical devices and biotechnology, the quality system requirements expects companies to document, assess, implement and then evaluate any and all changes made to equipment, utilities, systems and documents that impact GXP operations. One only has to look at the most common deficiencies cited by regulatory auditors to know that this activity continues to cause companies to struggle with how to implement and then manage such a program. Challenges faced include when to implement change control, the proper documentation of changes, the assessment of the overall impact to qualified systems and then how to assure the effectiveness of the changes made. A second challenge faced by manufacturing facilities is the review and approval of such changes before they are implemented and the larger the company, the greater the pressures not to delay such changes.

This course will look at the following items through interactive discussion and actual case studies, where applicable, to help illustrate the main points of an effective change control program. Topics will include the regulatory requirements for change control, the main topics to include in a change control SOP and review data sections of a typical change control form to use for the documentation and evaluation of changes. Challenges faced by companies to maintain an effective change control system will also be discussed along with the control of changes made to controlled documents.

Topics to be covered

This webinar will assist Companies in understanding the Regulatory requirements for conducting a GMP Compliant Temperature Mapping of their facility. Participants will learn how to complete a risk assessment, document a Temperature Mapping Protocol and a Summary Report.

The course details will include:

  • Review of regulatory requirements for change control by both the FDA and Health Canada
  • Review of the type of changes that can occur to equipment, utilities, systems, facilities, and documents.
  • Discuss when change control should be implemented and cases where it is not necessary.
  • Review topics to be considered during impact assessment of changes…such as training, procedures, drawings, regulatory issues, third party customer impact, additional testing needs, safety issues, etc.
  • Discuss challenges faced by industry delays in implementation, review process, capturing all changes proposed, emergency changes, evaluation of effectiveness of changes made.
  • Review the format for both a change control SOP and form for its documentation.
  • Review typical questions raised by auditors during inspections regarding change control practices.
  • Discuss change control as it applies to third party customers and vendors. What are the responsibilities of both parties and issues to address in quality agreements?

Questions and answer period upon course completion

Departments to which this course would apply

  • Regulatory
  • QA/QC
  • Manufacturing
  • Engineering
  • Validation
  • Packaging
  • Suppliers and/or Vendors
  • Third party customer representatives
  • Management

Benefits to be gained

The expectation for an effective change control program to assure the validated state of equipment, utilities and facilities is a basic premise found in the quality system regulations (QSR). In addition, change control is a routine area of focus by both the FDA and Health Canada inspectors. Knowing what to do and the management of such a program is one of the fundamental requirements to successfully get through a quality system audit. This course will give attendees the opportunity to review examples of change control forms, what to include in applicable procedures and case studies that will help highlight various points covered.


October 26, 2020
8:00 am - 5:00 pm