Writing and Managing SOPs for Clinical Quality Assurance
Course Objectives
SOPs play a crucial role in clinical quality assurance and it is therefore essential that they are understood and followed by all end-users in a clinical trial. If SOPs are not followed correctly, the validity of data generated is compromised, leading to warning letters being issued and delays in the trial process. Auditors and inspectors see SOPs as essential and following them is crucial.
In this highly interactive course you will develop the skills and practical experience required to write and review SOPs for GCP compliance. Participants will review GCP fundamentals and also relevant regulations. This knowledge will then be used to examine considerations of style, length and content.
What Will You Learn?
- Reduce early, or late stage, set backs in the registration procedure read more
- Maximise end-user compliance with GCP regulations read more
- Know what EU and FDA inspectors are looking for in organisation and application of SOPs read more
- Avoid common pitfalls in writing and managing SOPs read more
- Examine the impact of the EU GCP directive on your SOPs read more
Performance & Knowledge Objectives of this Course
• Integrate GCP requirements into your SOPs
• Avoid 483s and warning letters resulting from inadequate SOPs
• Create an efficient document management system to ensure the correct SOPs are being followed by the right people
• Understand the application of 21 CFR Part 11 on electronic management of your SOPs
• Survive the audit procedure and FDA/EU inspections
• Create SOPs focusing on the needs of your target audience
• Identify gaps and overlaps in SOPs
• Identify current regulatory trends in SOPs for GCP
• Increase the quality of your SOPs
Who Should Attend
This course is beneficial to all involved in writing or managing SOPs for clinical trials, particularly those working in the following departments:
- Quality Assurance
- Clinical Trials
- Clinical Development
- Clinical Operations
- Clinical Research
- Clinical R&D
- Clinical Project Management
Reviews
"Excellent course. Good balance between slide presentation, exercises and interaction"
"I found this course informative and useful"
"Brilliant, really enjoyed, tutor put everything over very well."
"Small group of participants, really interactive, practical"
Dates and Venues
29 Nov 2010 - 30 Nov 2010
Basel, Switzerland. To be confirmed
Related Events
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