Challenges of an Effective Change Control Program

Why Should You Attend:

An effective quality system program, along with several regulatory requirements, includes the documentation and evaluation of changes made to validated equipment, utilities, processes and controlled documents. To control this process, one must have both a defined change control procedure that outlines responsibilities and documentation requirements and a form by which required information is recorded. The effectiveness of these items will determine the success of your change control program and help assure regulatory auditors that your equipment, utilities and systems remain in a state of control.

This webinar will concentrate on three major points:

• The regulatory requirements for change control and what it applies to.
• How to develop a change control SOP that will define what is required, responsibilities, and a means to quickly provide summaries of changes to investigators.
• What are some of the common deficiencies cited by regulatory auditors?

In addition, the webinar will also highlight some of the benefits that a well maintained change control program provides to a company along with reviewing when change control is not required. Attendees will be able to ask questions on issues relating to their own change control procedure.

Learning Objective:

Attendance at this webinar will help attendees address the following concerns:

• What are current the regulatory expectations for change control?
• what are the typical components of a change control procedure?
• what are the typical deficiencies cited by regulatory auditors?
• What are the typical challenges to industry in trying to establish an effective program?

Areas Covered in the Webinar:

• Review the current regulatory requirements for change control.
• Discuss when change control needs to be implemented and the main items to be covered in the documentation of them.
• What are the major sections that need to be included in a change control procedure?
• What are the typical industry challenges associated with change control procedures?
• Review the benefits that a well-controlled change control process can provide.
• What are the most common deficiencies cited by regulatory auditors when auditing change control programs?

Who Will Benefit:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Suppliers and Vendors
• Process owners
• Quality engineers
• Quality auditors

Kenneth Christie
Chief Operating Officer, VTS Consultants Inc

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, equipment and utilities, medical devices, and solid dosage processes 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 served 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.

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