Basic Requirements for IQ, OQ and PQ Protocols

  • Speaker:Kenneth Christie
  • Date: 20th October 2017 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90183

$1,450

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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 are also 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.

Areas Covered in the Session:

  • 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.

Instructor Profile :

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.                                                                                                                                                                                                                                       

Available Options

5 Member Group

$825

10 Member group

$1,675
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