AAPS Career College
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Investigations of Atypical and Out of Specification Laboratory Results

A ONE DAY COURSE

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Distinguished Faculty

Gregory P. Martin
President
Complectors Consulting LLC
Pottstown, PA

Greg Martin is President of Complectors Consulting (www.complectors.com) which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.  He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources.  Mr. Martin has over 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years.  In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules.  He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group.  He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance.  He can be contacted at greg.martin@complectors.com.


Registration Fee Includes

Presentation Materials, Luncheon, Refreshment and Free Parking

Note: Please indicate any special Dietary requirements when registering for the course

Dates Available

May 30, 2012

Time

9:00 a.m. – 5:00 p.m.

Cost

CAD $685.00 + HST

Location

AAPS Training Center
200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4
Tel: 416-502-2277

Goals and Objectives

This course is designed to provide sound training on how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations

Upon completion of this course the learner should:

  1. Be familiar with various terms associated with investigations of atypical or out of specification results, and how to document those investigations.
  2. Be familiar with the FDA Guidance for Industry on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production and how to apply it in laboratory situations.
  3. Be able to create a Laboratory Investigation Checklist and effectively document an investigation, including rationale and results.
  4. Know the importance of Corrective and Preventative Action (CAPA) and be able to identify appropriate CAPAs.
  5. Understand practical strategies to utilize outcomes from investigations for continuous improvement and reduction of future OOS results.

Contents

Who Should Attend

Chemists, Supervisors and Managers in Pharmaceutical Laboratories and Quality Assurance Personnel responsible for generating or evaluating test results in a regulated environment.

Certificate of Attendance and Course Material