OOS Investigations in a GMP environment (2 day)

This course provides helpful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOP’s. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP’s play in achieving the required level of compliance and quality. 

The course material is presented by means of slides, handouts and participation of the attendees through discussion and individual/group exercises.

Note: Participants may bring an SOP related to their work for the workshop exercise on day two.

The workshop emphasises practical issues such as:

·         The benefits of SOP’s

·         The logical approach to defining and writing the procedure section of the SOP

·         Writing SOP’s as part of a team

·         Critiquing an example of a badly written SOP

The course provides ample opportunities for group discussions and hands on exercises. It enables participants to gain the skills and knowledge necessary to meet the expectations of regulatory agencies.

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 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
learnings 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

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