Best Practice for Writing Effective SOPs (Standard Operating Procedures) Training Course

An essential course for ensuring compliance with regulatory requirements and including best practice SOP writing using process mapping.

18 July 2024
+ 12 December 2024 »
from £549

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Format: Live online
CPD: 6 hours for your records
Certificate of completion

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Course overview

Standard operating procedures (SOPs) play a crucial compliance role with regulations. It is therefore essential that they are well written and easy to use. 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 interactive SOP course has been specifically designed to help you develop the skills to write and produce the content of SOPs using a best practice process including process mapping, review and implement SOPs and ensure you comply in a regulated environment.

You will come away with the confidence to use a best practice process to write, update and implement effective SOPs.

Benefits of attending:

Master the art of writing user-friendly SOPs
Learn how to prepare the content of SOPs including process mapping
Discover how to implement and manage SOPs effectively
Carry out effective SOP training
Ensure your SOPs incorporate appropriate regulatory requirements

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

Who should attend?

All those in pharma, biotech, generics, devices and animal health industries who are involved in preparing, reviewing and/or managing SOPs
Ideal as an introduction and also helpful to those wanting to ensure they are aware of best practice
Particularly relevant for those in GxP areas including clinical research, pharmacovigilance, QA, regulatory affairs and GMP

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The Best Practice for Writing Effective SOPs course will cover:

Fundamentals of Effective SOPs

When are SOPs needed and why?
The difference between SOPs, policy documents, work instructions and local guidance
Determine the scope, roles and responsibilities associated with SOPs
Identify the essential structure of SOPs
Share best practice: what makes a good SOP?
Identify who should write, review and authorise SOPs
Current thinking in writing SOPs
Application of process mapping for writing SOPs
Example of a best practice SOP

Write Concise and User-Friendly SOPs

Translate the flow of operations into the document
Write SOPs that are sufficiently detailed, but not restrictive and limiting
Understand the target audience and account for end users’ needs
Tips for how to write the content, format, style and presentation
Defining SOP content using mind-mapping and process-mapping/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
Exercise: write an SOP using best practice methodology

Practice preparing an SOP

Ensuring Your SOPs Meet Regulatory Requirements

What needs to be included for compliance in GxP areas?
Current regulatory trends
Tips for what auditors and inspectors look for when they review SOPs

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Laura Brown
LB Training and Development Ltd

Dr Laura Brown is an independent pharmaceutical QA consultant and is a recognised expert in QA including auditing SOPs for regulatory compliance. She has more than 25 years’ international experience in the pharmaceutical industry in a number of senior roles and has worked for companies including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in several quality assurance roles which have included writing, reviewing and auditing SOPs and CAPA implementation and has helped companies prepare SOPs and review CAPA systems to meet regulatory requirements.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

18 July 2024

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 13814

GBP 549 649
EUR 789 929
USD 893 1,049

Until 13 Jun

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

12 December 2024

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 14087

GBP 549 649
EUR 789 929
USD 893 1,049

Until 07 Nov

1 day live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.