Writing Effective SOPs in a GMP Environment
Course
In Islington
Description
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Type
Course
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Location
Islington
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Duration
2 Days
It enables participants to gain the skills and knowledge necessary to meet the expectations of regulatory agencies. Suitable for: All personnel who are involved in the organisation, writing or management of SOP's required for GMP purposes. Quality Assurance. Documentation and Technical Writing. Quality Control Laboratory. Regulatory Affairs. Contract Laboratory. Analytical Laboratory. Project Management. Training. Validation. Consultants
Facilities
Location
Start date
Start date
Reviews
Teachers and trainers (1)
Pauline McGregor
Course Speaker
Pauline has 20 years experience working for pharmaceutical companies and contract testing laboratories in both Canada and the UK.
Course programme
Overview
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore the most popular documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices and are followed as written.
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.
This course will deliver the tools to enable you to:
- Understand the purpose and benefit of effective SOPs
- Understand the critical role of SOPs in Quality Documentation systems
- Use various tools such as flowcharting to define a logical procedure
- Write a concise, unambiguous SOP for its intended purpose
- Ensure the document is written for the correct audience
- Link SOPs to good documentation practices
- Define clear responsibilities in order to promote action and closure within the document
- Manage revisions, non conformance and deviations from a current SOP
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
Writing Effective SOPs in a GMP Environment