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Pharmaceutical Documentation – a practical approach

 
  February 27, 2010  
     
 
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

 
 
Organized by: PharmaTraining
Invited Speakers:

Dr Michael Gamlen, Pharmaceutical Development Services

 Dr Pauline McGregor, PMcG Consulting

 
Deadline for Abstracts: N/A
 
Registration: Register on website
E-mail: judy@pharma-training-courses.com
 
   
 
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