A Two-day Interactive Course, with Case Study and Workshop Discussions on:

- The basic scientific concepts behind FDA's investigation requirements
- Regulatory Expectations
- Review of FDA’s latest guidance on OOS/OOT
- Warning Letters from FDA 483's – Recent Case Studies
- Defining OOS/OOT Results
- Implementing proper OOS Management
- Developing an OOS Investigation Procedure and Forms
- Common Mistakes and Pitfalls when Conducting an OOS Investigation
- Conducting OOS/OOT Investigations and Evaluating results
- Understanding the responsibilities of laboratory analysts and supervisors
- Knowledge of testing types required to determine the validity of an OOS
- Awareness of what the FDA will be looking for in terms of Human Errors
- Strategies for handling retests when investigations are inconclusive
- Tracking and Trending Lab investigations
- Checklist Approach to determine sources of error
- Evaluating the validation of analytical methods
- Comprehension of the product impact when documenting out-of-trend (OOT) results
- Types of required tests to determine the validity of the OOS
- Understanding the frequency with which to conduct re-testing and re-sampling
- Root Cause and CAPA Strategies
- Quality Systems Approach to OOS
- Examples of industry failures and misunderstandings
- Identification of Out-of-Trend Stability Results

Distinguished Course Leaders

Ms. Gabriela Bodea
Sr. Quality Systems Specialist
Abbott Point of Care

Mr. Alexander M. Hoinowski
Senior Consultant
The Quantic Group

Ms. Jamie Jamshidi
President
PQC Consulting, Inc.