PharmaTraing, Window Conference Centre, Islington, London
17 & 18 June 2010
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 - Introduction – Why Document?
- Quality management Systems
10.30 Morning refreshments
Morning Session 2 - 10.45 am to 12.45pm
Introduction to key documents and their relationships - SOPs
- Protocols
- Master Formulae
Exercise “Tasty Tablets”
Master production documents - Manufacturing Record
- Packaging Record
- Batch Records
- Spoecifications
12.45 Lunch
Afternoon Session 1 - 13.45 to 15.15pm
Additional Manufacturing documents - Warehousing
- Sampling
- Weighing/dispensing
- Batch Manufacturing records
- Product testing and release
Training and qualification of personnel 15.15 Afternoon refreshments
Afternoon Session 2 - 15.30 to 17.30pm
Validation Documentation - Validation overview
- Validation master plans
17.30pm End of day
Day 2
Morning Session 1 - 9.00 to 10.30am
Validation Documentation (continued) - User Requirement Specification (URS)
Exercise - Validation protocols
- Equipment/Instrument Qualification (IQ/OQ/PQ)
- Validation report
10.30 Morning refreshments Morning Session 2 - 10.45 am to 12.30pm
Documentation in the Laboratory - GMP requirements of Laboratory notebooks, raw data and log books
- SOPs
- Certificate of Analysis
- Test methods
- Protocols and Reports
12.30 Lunch
Afternoon Session 1 - 13.30 to 15.15pm
Documentation Control - Common elements and standards
- Generation, review, approval
- Numbering systems
- Document Management
- Summary to successl
Product development documentation in practice - Determining the specifications for drug product (case study)
15.15 Afternoon refreshments
Afternoon Session 2 - 15.30 - 17.00pm
Stability testing and documentation
Individual documents (participants are asked to bring an example of a document related to their work for this segment)
17.00pm End of day
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