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HUM-MOLGEN
-> Events
-> Courses and Workshops |
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April 03, 2013 |
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PharmaTraining Ltd, London UK
10 & 11 October 2013
Day 18.30 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
- Specifications
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 2Morning 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 refreshmentsMorning 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 documentationIndividual 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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Organized by:
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PharmaTraining Ltd |
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Invited Speakers:
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Dr Pauline McGregor
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Deadline for Abstracts:
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Registration:
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Early-bird fee: £1062 if booked and paid by 16 August 2013 Full fee: £1180. Registration is available on website: http://www.pharma-training-courses.com/pharmaceutical-documentation_5.htm
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E-mail:
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judy@pharma-training-courses.com
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