CAPA and OOS investigations

Down load a complete brochure with registration form

Corrective And Preventative Actions (CAPA)

and

Out Of Specification Investigations (OOS)

(for pharmaceutical products)

Course Dates: 14 & 15 December 2009

Venue: Window Conference Venue, Islington London

Course Cost: £1160.00 + VAT £174 - Total £1334.00

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

Crucial elements
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 Crucial elements 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)