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Writing Effective SOPs in a GMP Environment

 
  February 27, 2010  
     
 
PharmaTraining, Window Conference Centre, Islington, London
14 & 15 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
• Individual Exercise
• Benefits of SOPs
• Global Harmonisation of SOP’s

10.30 Morning refreshments

Morning Session 2 - 10.45 am to 12.30pm
• Overview of Regulatory Expectations
• The Role of SOP’s in Quality Documentation Systems
• Good Documentation practices

12.30 Lunch

Afternoon Session 1 - 13.30 to 15.00pm
• SOP Maintenance
• Group discussion (Paper versus electronic maintenance)

15.00 Afternoon refreshments

Afternoon Session 2 - 15.15 to 17.15pm
• Designing an SOP template
• Exercise (groups of 2 or 3 people)

17.15pm End of day

Day 2

Morning Session 1  - 9.00 to 10.30am
• Review exercise for end of day 1
• The team approach to SOP writing
• Defining responsibilities and knowing the audience

10.30 Morning refreshments

Morning Session 2 - 10.45 am to 12.30pm
• Ensuring the flow of the document
• Group exercise
• Writing tips for a concise, unambiguous document

12.30 Lunch

Afternoon Session 1 - 13.30 to 15.15pm
• Writing tips for a concise, unambiguous document (continued)
• SOP’s as a training tool
• Exercise – critique a badly written SOP
• SOPs and the Change Control System

15.15 Afternoon refreshments

Afternoon Session 2 - 15.15 to 17.00pm
• Managing revisions, Non-conformance and Deviations
• Final Advice and Summary
• Individual SOP work

17.00pm End of day
 
 
Organized by: PharmaTraining
Invited Speakers: 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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