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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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September 01, 2009 |
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Pharma Training Services, Window Conference Venue
2009-12-14
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)
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Organized by:
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PharmaTraining Services |
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Invited Speakers:
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TBA
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Deadline for Abstracts:
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N/A
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Registration:
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Register online at course website.
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E-mail:
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judy@pharmatrainingservices.com
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