Face-to-face and blended
learning for corporate clients

How to Write SOPs to Comply with GCP

Duration: 1 day (2 day version also available)

How to write concise and user friendly SOPs

Implement and manage SOPs effectively

Ensure your SOPs incorporate appropriate regulatory requirements

All those in who will be or are involved in preparing, reviewing and/or managing

SOPs for clinical trials or pharmacovigilance.

Helpful to those wanting to ensure they are aware of best practice.

1. Introduction and Objectives

2. How to Write Concise and User Friendly SOPs

• When and why are SOPs needed?

• What is the difference between having SOPs and work instructions/local guidance?

• Format, content, style and presentation

• Translation of the activities into the SOPs

• Writing SOPs that are sufficiently detailed but not overly restrictive

• Defining SOP content using mind mapping and flow charting

3. SOP Implementation and Management

• Review and approval processes for SOPs

• Handling updates – when and how should SOPs be updated?

• Distribution and version control

• SOP training

• How to maximise end-user compliance

• Tips for what auditors and inspectors look for when they review SOPs

4. Ensuring your SOPs include Appropriate Regulatory Requirements and Objectives

• What level of regulatory requirements should be in SOPs?

• What topics should the SOPs cover?

• What needs to be included for compliance? - GxP areas including clinical research,

pharmacovigilance, regulatory affairs and GMP

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