A One and half day Interactive Course & Workshops Featuring:
Regulatory Expectations for Compliant OOS Procedures
Developing the OOS System as Part of Your Quality Program
Review of FDA's latest Guidance on OOS/OOT
Warning Letters from FDA 483's - Case Studies
Defining OOS/OOT Results
Implementing Proper OOS Management
Common Mistakes and Pitfalls when Conducting an OOS Investigation
Developing OOS Investigation Procedure and Forms
Conducting OOS/OOT Investigations and Evaluating results
Using a Checklist Approach to Determine Sources of Error
Differentiating Responsibilities of Laboratory Analysts and Supervisors
Testing Types to Determine the Validity of an OOS
How to Handle Retests when Investigations are Inconclusive
Tracking and Trending Lab Investigations
Product Impact when Documenting Out-of-Trend (OOT) Results
Types of required tests to determine the validity of the OOS
Determining Re-testing and Re-Sampling Frequency
Root Cause and CAPA Strategies