DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/5lv7v2/how_to_write_sops) has announced the addition of the "How to Write SOPs - An Essential Course for Ensuring Compliance with Regulatory Requirements (Seminar, London)" conference to their offering.

The How to Write SOPs seminar will take place on the 7th July 2014 at The Rembrandt Hotel, London.

Particularly relevant for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP and Data/Document Management Functions.

BENEFITS OF ATTENDING:

- Learn How to Write Concise and User Friendly SOPs

- Understand How to Prepare the Topic Content of SOPs

- Ensure You Implement and Manage SOPs Effectively

- How to Carry Out Effective SOP Training

- Ensure Your SOPs Incorporate Appropriate Regulatory Requirements

SOPs play a crucial role in compliance with regulations. It is therefore essential that they are well written and easy to use by the end-users. If SOPs are not followed correctly, the validity of data generated is compromised, leading to inspection findings and non compliance issues which could lead to delays in bringing a drug/device to market.

This SOP course has been specifically designed to help you develop the skills to write, produce the content of SOPs, review and implement SOPs and in particular to be able to comply in a regulated environment. It is essential therefore to have a number of SOPs, and for existing SOPs to be reviewed and updated regularly. Otherwise this is likely to result in major findings by regulatory inspectors. Participants will come away with the confidence to use a process to write, update and implement SOPs which can easily be used by the end users.

WHO SHOULD ATTEND

- All those in Pharma, Biotechnology, Devices and Veterinary industries who will be or are involved in preparing, reviewing and/or managing SOPs

- Ideal as an introduction to preparing, reviewing and implementing SOPs and may also be helpful to those wanting to ensure they are aware of best practice

- Particularly those in GXP areas including clinical research, pharmacovigilance, regulatory affairs and GMP

Certificates of Attendance for Professional Development will be given to each participant who completes these seminars.

Key Topics Covered:

Introduction and Objectives

How to Write Concise and User Friendly SOPs

- When are SOPs needed and why?

- 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 sufficiently detailed SOPs, but which are not restrictive

- Defining SOP content using mind mapping and flow charting

SOP Implementation and Management

- Review and approval processes for SOPs

- Handling updates - when should SOPs be updated and how?

- Distribution, version control

- SOP training

- How to maximise end user compliance

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

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

Final Questions and Close

For more information visit http://www.researchandmarkets.com/research/5lv7v2/how_to_write_sops