| |
|
|
| |
|
|
| |
HUM-MOLGEN
-> Events
-> Courses and Workshops |
|
|
| |
| |
| |
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp,
Frank S.
Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved.
Liability, Copyright and Imprint. |
|