The Challenges of Change Control: Its Implementation and Maintenance

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 a combination of classroom instruction, group activities, handouts and actual case studies 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 examples of a change control form to use for the documentation and evaluation of changes. In addition, the course will use actual class examples of various changes and then perform an evaluation of how to assess the change and its potential impact. Handouts will include examples of a change control SOP and form used for the documentation of proposed changes with the opportunity to openly discuss questions and make suggestions. Challenges faced by companies to maintain such systems will also be discussed along with the control of changes made to “controlled” documents.

• 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.

• Class exercise- Discuss an actual change and how the assessment process would work.

• Review the format for both a change control SOP and form for its documentation.

• Discuss an example of an actual SOP and form used for change control. Critique for both good and poor or missing items.

• 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

The course material is presented by means of slides, handouts and participation of the attendees through discussion. Questions and answers will be taken throughout the duration of the course.

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 Amhesrt, 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 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’s 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.