PharmaTraining Limited, Window Conference Venue, 13 Windsor Street, Islington, London, N1 8QG, United Kingdom
2011-10-13
This course provides helpful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOP’s. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP’s play in achieving the required level of compliance and quality. The course material is presented by means of slides, handouts and participation of the attendees through discussion and individual/group exercises. Note: Participants may bring an SOP related to their work for the workshop exercise on day two. The workshop emphasises practical issues such as:
• The benefits of SOP’s
• The logical approach to defining and writing the procedure section of the SOP
• Writing SOP’s as part of a team
• Critiquing an example of a badly written SOP The course provides ample opportunities for group discussions and hands on exercises. It enables participants to gain the skills and knowledge necessary to meet the expectations of regulatory agencies. 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 refreshmentsMorning Session 2 10.45 am to 12.30pm
• Ensuring the flow of the document
• Group exercise
• Writing tips for a concise, unambiguous document12.30 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 refreshmentsAfternoon 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
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