OOS investigations in a GMP environment

To be re-scheduled
Venue

Speaker Pauline McGregor
Cost £1160 + VAT UK
Early-bird rate £1044.00 + VAT UK

Available as an in-house course

Overview

This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, determining the extent of the investigation during Phase I and Phase II, documenting findings determining root causes and assigning corrective and preventative actions.

This course is presented in a dynamic environment created by a power point presentation, interactive exercises, case studies and group discussion. Participants are welcome to bring their own examples for group discussion sessions.

The workshop emphasizes practical issues such as:

The importance of good quality support systems
FDA audit observations and how they could have been avoided
Case studies
A detailed guide to conducting Phase 1 and Phase II of the investigation
Reporting and evaluating passing and failing results

The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet current regulatory expectations. The course material is based on the FDA guideline “Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production”, October 2006

This course will deliver the tools to enable you to

Understand regulatory requirements and documentation regarding OOS investigations
Understand the critical role GMP compliance has on simplifying OOS investigations
Compile your own checklist for Phase 1 and Phase 2 OOS investigations
Adjust your quality systems and SOPs to ensure OOS investigations are more effective
Perform a successful OOS investigation in your own work environment
Determine a feasible root cause for an OOS result
Assign and follow up on effective corrective and preventative actions

Who should attend:
This Two-day course is valuable for Directors, Managers, Supervisors, Laboratory Analysts and Associates working in a GMP environment in the Pharmaceutical and related industries with daily responsibilities in the following areas:

Quality Assurance
Documentation and Technical Writing
Quality Control Laboratory
Regulatory Affairs
Contract Laboratory
Analytical Laboratory
Project Management
Training

Course outline
Questions and answers will be taken throughout the duration of
the course.

Day 1
8.30 Registration and Coffee

Morning Session 1
9.00 to 10.30am

Definition and categories of OOS Results
Review of FDA’s guidelines (Oct 2006)
Examples and case studies of regulatory observations
Quality documentation required to support OOS investigations

10.30 Morning refreshments

Morning Session 2
10.45 am to 12.30pm

Responsibilities
Defining the main categories of OOS results
Investigating OOS results - Phase 1
- Flow chart
- Checklist

12.30 Lunch
Afternoon Session 1
13.30 to 15.15pm

Investigating and OOS result Phase 1 (continued)
- Determining the root cause
- Common Laboratory errors
Regulations and industry response to invalidating OOS results

15.15 Afternoon refreshments
Afternoon Session 2
15.30 to 17.30pm

Phase 1 Case studies

These are interactive group exercises where the participants utilise their experience and new learning’s to figure out more appropriate action than that which was taken as described in the examples. Their answers are then compared to the actual FDA response. Group discussions follow.

17.30pm End of day

Day 2

Morning Session 1
9.00 to 10.30am