Corrective And Preventative Actions (CAPA) and Out Of Specification Investigations (OOS) (for pha

Venue: Window Conference Venue

Location: London, United Kingdom

Event Date/Time: Dec 14, 2009 End Date/Time: Dec 15, 2009
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Description

Course objectives:

This two-day interactive training course will guide and develop your understanding of:

* Regulatory Requirements for CAPAs and OOS Investigations
* Secure Strategies for Compliance
* How to Maximise Benefits from CAPAs and OOS Investigations
* How to Manage Typical Issues that Arise



Both European Regulators and FDA expect pharmaceutical products manufacturers to have in place an effective system for CAPA to correct process deficiencies and maximise process improvement. A high proportion of observations/citations relate to inadequate or incomplete CAPA. In addition, manufacturers must have a secure system for management of Out of Specification Results (Non-Conformances) to ensure that all products on the market are safe and meet their registration requirements.



Since there are many shades of opinion on these subjects, all presentations will be as interactive as possible to allow delegates to contribute to the overall learning from the course.



Who will benefit:

This training course will be of practical importance to the following:

* QA Managers
* Qualified Persons
* QC Laboratory Managers
* Production Managers
* Regulatory Compliance Managers
* Process Validation Engineers
* Engineering Managers
* Chemical Engineers
* Process Development Managers
* Warehouse Managers
* Logistics Managers
* QA Inspectors

Course Programme:

Agenda for Day 1

CAPA in the Pharmaceutical Products Industry

08.30-08.45


Registration

08.45-09.00



09.00-09.45







09.45-10:45


Introductions and Outline of Agenda – CAPA is the first part of Process/ GMP CAPAbility

Basic understanding of CAPAs

* Correction, Corrective Action and Preventive Action
* Correction and long term CAPAs
* Where/when are CAPAs required?
* FDA / 21CFR requirements for CAPAs and CAPA management (21CFR Part 820.100)
* European GMP Guidelines and CAPA

Common misconceptions about CAPAs

* Why are CAPAs necessary?
* Common problems and misconceptions about CAPAs
* CAPAs and Risk Assessment
* Root cause analysis techniques (KT; FMEA; Fishbone; 5 Whys; etc)

10:45-11:00


Coffee/Tea Break

11:00-11:45



11.45-12.30


Workshops:

1. Sources of data (trending, etc)

2. Classification of the Severity of the deviation or incident

Principles of Critical Deviation Management (CDM)

* Using CAPAs only for CRITICAL deviations
* Management and trending of non-critical deviations
* Trends leading to Preventive Action

12:30-13.30


Lunch

13.30-14.00



14.00-15.00


FDA inspection of CAPA sub-system (from FDA QSIT guide)

* How FDA/regulatory inspectors will investigate your CAPA system



Workshops:

3. Practical management of CDM

4. CAPAs from complaints / returns / recalls

15:00-15:15


Coffee/Tea Break

15:15-16.00



16.00-16:45


How to Avoid Too Many CAPAs

* Applications of Risk Assessment
* Application of CDM

Responsibilities for Tracking and Close Out of CAPAs

Documentation (CAPA SOP and CAPA control form)

* Implementation
* Dissemination
* Review
* Pitfalls

16:45-17:00


Open Forum

* Discussion of CAPA so far



Agenda for Day 2

Investigation of Out of Specification Results

08.30-09.15

09.15-09.25



09.25-09:50







09.50-10.30


Workshop:

5. Design a CAPA control form

Linking CAPAs to OOS results

* Why are they connected?
* What is the connection?

What is an “Out of Specification” (OOS) Result?

* Definition of OOS
* Common Misconceptions
* The role of the QC Laboratory
* The role of Quality Assurance
* Stability trials / Field Alert Reports

CASE STUDIES

* Production instrumentation
* Laboratory non-conformances

10:30-10:45


Coffee/Tea Break

10:45-11:15





11.15-11.45



11.45-12.30


How to Investigate an OOS Result

* Phase 1 – Laboratory Investigations
* Responsibilities of the Analyst
* Responsibilities of the Laboratory Supervisor / Investigator
* Structured Laboratory Investigation
* Plan – Review – Plan – Review – etc.

Workshop – Control of Laboratory Investigations

6. Design a procedure/record for Laboratory Investigations

o Crucial elements
o Nice to Have elements

Investigating a Confirmed OOS Result

* Review of production records
* Sample integrity and Resampling
* Additional Lab work (information gathering)
* Hypothesise – Plan – Review – (Hypothesise – Plan – Review)
* Reporting Test Results

Avoiding the accusation of “Testing into Spec”

12:30-13.30


Lunch



13.30-14.15



14.15-14.45





14.45-15.15


Workshop – Control of Full Scale OOS Investigation

7. Design a procedure/record for full scale OOS Investigations

o Crucial elements
o Nice to Have elements

Averaging, Outliers and Out of Precision

* Assessment of Out of Precision replicates
* When is averaging allowed?
* When is averaging not allowed?
* Use of the Outlier test

Workshop

8. Use of retesting, resampling and “additional information”

15:15-15:30


Coffee/Tea Break

15.30-16.00





16.00-16.20




Concluding and Closing Out OOS Results

* Interpreting results
* Data Review (contemporary and retrospective)
* The contribution of CAPA
* Cautions and Cautionary Tales

Conclusions: (Summing Up)

* Summary of Principles and Practıce of CAPA
* Key Messages from CAPA
* Summary of Control of Laboratory Investigations
* Summary of Control of Expanded Investigations
* Key Messages from Laboratory/OOS Investigations

16:20-16:45


Questions and Answers

Close of course

Delegates will also receive sample copies of forms:

* Investigation of Quality Incident /Nonconformity
* Corrective and Preventive Action - CAPA Tracker

Copy of FDA Final Guidance Document (for Day 2)

Venue

13 Windsor Street, Islington
London
United Kingdom
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