OOS investigations in a GMP environment

Course objectives:

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

• Investigating OOS results Phase 2

• Flow chart

• Checklist

• Examples of  root causes found during Phase 2 investigations

 10.30 Morning refreshments

Morning Session 2

10.45 am to 12.30pm

• Case studies Phase 2

12.30 Lunch

Afternoon Session 1

13.30 to 15.15pm

• Additional Laboratory Testing (Retesting and Resampling)

• Reporting Test Results

• Concluding the Investigation and Evaluating the results

15.15 Afternoon refreshments

Afternoon Session 2

15.30 to 17.00pm

• Corrective and Preventative Actions

• The Audit Trail

• Minimising future OOS results

17.00pm End of day