Thursday February 23, 2012
LIVE Webinar
Conducting Out of Specification (OOS) Investigations
Live Webinar Series
Module 1
Date: Wednesday January 25, 2012

Module 2
Date: Wednesday February 1, 2012

Registration Single Attendee Per Module: CAD $195.00
Group rates are available. (see below)

All rates are subject to the Canadian 13% Harmonized Sales Tax (HST)
Time: 1:00 PM ET | 10:00 AM PT Duration: 2 hours with Q&A
Introduction

Analytical testing of active pharmaceutical ingredients (APIs) and drug products within Quality Control (QC) and Analytical Development (AD) groups in accordance with product specifications is a regular every day activity within the pharmaceutical industry. Occasionally, things go wrong and a result is reported which does not meet a specification requirement. On these occasions thorough investigations must be conducted and these are out of specification (OOS) investigations.

This is intended as a refresher course which is designed to discuss approaches that will ensure that OOS investigations are conducted in thorough systematic fashions and in ways that will meet the requirements set out in FDA guidelines.

  • Enhance understanding of history and regulatory expectations
  • Identify examples of regulatory inspection observations of poor investigation practices
  • Provide strategies that will ensure thorough investigations and sound Corrective and Preventative Actions (CAPA)
  • Establish OOS approaches that will lead to successful regulatory inspections
Course Outline

Module 1

Date: Wednesday January 25, 2012

Contents:

  • Some History and Regulatory Guidelines
    • Some Background and Details of Barr Case
    • Discussion of FDA Guideline
  • Important Investigation Principles
    • OOS/OOT/Unexpected Results
    • Phase I and Phase II Investigations
    • Inconclusive Investigations
    • Retesting/Reanalysis/Resampling
    • CAPA
  • Examples of Deficiencies

Module 2

Date: Wednesday February 1, 2012

Contents:

  • Quick Review of Session 1 Highlights
    • Guidelines
    • Investigation Principles
    • Importance of Avoiding Deficiency Letters
  • Designing an OOS Investigation SOP and How to Conduct
    • Phase I Laboratory Investigations
    • Phase II Full Scale Investigations
    • Examples that Require Special Approaches
      • Microbiological Methods
      • Staged Testing Methods
      • Swab Samples from Cleaning Verifications
    • Dealing with Inconclusive Investigations
    • Designing CAPA
  • Examples
    • Case Studies to Demonstrate Applications of Investigations,
Who Should Attend
  • Analytical Development Managers/Scientists
  • Stability Scientists
  • Project Management
  • Formulation Development
  • Quality Control Managers/Analysts
  • Quality Assurance
  • Regulatory Affairs
  • Compliance
  • Manufacturing
  • Validation
  • Consultants
Speaker
Dr. Geoff Carr
Director, Analytical Development, Canada
Patheon Inc.

Dr. Geoff Carr was appointed as Manager, Analytical Development at Patheon Inc, Ontario, Canada in 2000 and is now Director, Analytical Development. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. His academic background is in Chemistry and he has a PhD from London University in Synthetic Organic Chemistry. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees and is currently a Member of the 2010-2015 Cycle USP General Chapters – Chemical Methods Expert Committee. He is the author of numerous papers and presentations at international conferences on various topics related to Pharmaceutical Analysis.

Rates

Single Attendee: CAD $195.00

Group of 5 or less per location: CAD $400.00
Group of 6 to 10 attendees per location: CAD $750.00
Group of 11 to 20 attendees per location: CAD $1250.00

Single attendee refers to single participant at a single computer/login.

Group rates only apply to candidates who wish to have more than one attendee, but will be attending the webinar from a single computer/login. If multiple candidates wish to login at different locations, it will be considered as a separate additional registration and will require more than one webinar login information. Also note that one login information will only be valid on one computer.

Please contact us at webinar@ipacanada.com for multiple-location group rates or any other enquiries.

Copyright © 2012 www.ipacanada.com - International Pharmaceutical Academy - All Rights Reserved.