Basic Requirements for IQ, OQ and PQ Protocols

Why Should You Attend:

Any equipment, system or utility used for GMP impacted products or services must demonstrate they are suitable for their intended use and operate according to their design and functional specifications. To prove these requirements, the protocols developed for both installation and operational verification (and others) are expected to be in place, be based on defined user and functional specifications and approved prior to use. This webinar, designed for those just starting to be responsible for qualification activities, will help establish an outline of the basic components for these two protocols. Benefits of a good summary report will also be briefly reviewed. In addition, common deficiencies cited by regulators will also be reviewed in order to help attendees avoid similar issues when their protocols are audited.

Current regulatory requirements state the need to prove and document that equipment, systems and utilities are verified to perform their desired functions. This verification and documentation comes in the form of qualification protocols that verify proper installation, adequate support utilities, operation over its entire range, and acceptable performance according to established procedures and operational set points. This webinar will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. Attendees will be given the chance to ask questions regarding their own protocols and actual case studies will be used to highlight various points.

Areas Covered in the Webinar:

• Review common protocol types and the typical information included in each.
• Discuss common deficiencies cited with each type.
• Review how best to summarize results and the handling of deviations encountered.
• Discuss questions that attendees may have regarding their current practices.

Who Will Benefit:

• Quality Assurance
• Quality Control
• Manufacturing
• Production
• Regulatory
• Laboratory Personnel
• Management
• Equipment Vendors

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 Amhesrt, MA. His responsibilities specifically 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. He 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, he serves as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.

Mr. Christie has a BS degree in biology from Shippensburg State University (PA) and an executive MBA degree from Michigan State.

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