How to Write Effective SOPs

An essential course for ensuring compliance with Regulatory Requirements which will be of particular relevance for Pharmacovigilance, Regulatory Affairs, Clinical Research/Operations, GMP, QA and Document Management Functions

27 Jun 2019

& 2 Dec 2019 , 25 Jun 2020

GBP 699
EUR 979
USD 1,090

Book now

Course Overview

SOPs play a crucial compliance role 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 and produce the content of SOPs using a best practice process, review and implement SOPs and
ensure you comply in a regulated environment.

You will come away with the confidence to use a process to write, update and implement SOPs which can easily be understood by the end users.

Please note we are also running:

Book both

This meeting runs back-to-back with Improving Processes and CAPA (Corrective and Preventative Action) and there is a further £100/€140 discount off when booked together.

To register on both events click HERE

To find out more call Customer Services on +44 (0)20 7749 4730 or e-mail info@management-forum.co.uk

Benefits of attending

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

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

Course programme

How to write concise and user friendly SOPs

  • When are SOPs needed and why?
  • Discuss the difference between having SOPs, policy documents, work instructions and local guidance

Review the fundamentals of SOPs

  • Determine the scope, roles and responsibilities associated with SOPs
  • Identify the essential structure of SOPs
  • Discussion to share best practice: what makes a good SOP?
  • Identify who should write, review and authorise SOPs
  • Current thinking in writing SOPs and an example of a good 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 limitingUnderstand the target audience and account for end user’s needs
  • Tips for how to write the content, format, style and presentation
  • 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
  • Exercise: write an example SOP

Ensuring your SOPs meet regulatory requirements

  • What needs to be included for compliance in GMP areas?
  • Current regulatory trends
  • Identify common SOP deficiencies
  • Tips for what auditors and inspectors look for when they review SOPs

Presenter

Laura Brown

Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.

Book now

27 Jun 2019
27 Jun 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
2 Dec 2019
2 Dec 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
Enrol now
25 Jun 2020
25 Jun 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

You may also be interested in

Previous customers include...

  • 3M Healthcare Ltd
  • Azad Pharma AG
  • CERA SAS
  • Chiesi Ltd
  • Copenhagen HIV Programme
  • Cyberonics Europe BVBA
  • CYTOS Biotechnology AG
  • Dermal Laboratories Ltd
  • EGIS Pharmaceuticals PLC
  • Grupo Ferrer Internacional SA
  • H. Lundbeck A/S
  • IBA
  • Institute for Energy Technology
  • Laboratorios Andromaco SA
  • LEO Pharma A/S
  • Lundbeck (Ireland) Ltd
  • Medical Device Usability Limited
  • MSD Ltd
  • Novo Nordisk
  • Nycomed UK Limited
  • Pronova BioPharma Norge AS
  • Roche Products Ltd
  • s.a. Lundbeck nv
  • SC Pharma Serv International Srl
  • Servier Laboratories Ltd.
  • Sharp Life Science (EU) Ltd
  • South West London Cancer Research Network
  • Uteron Pharma (UPO)
  • Wesley Coe (Cambridge) Limited
  • Zoetis

Approachable and encouraged interaction. Excellent presenter, group size and format. Liked interactive approach and practical exercises. Examples [were] really helpful.

Miranda Dunstan, Clinical Process Improvement Specialist, GW Pharmaceuticals Ltd

Very knowledgable, very pleasant speaker. Content covered a broad area - useful for professional writers and SME assigned the task.

Elisabeth Smith, Senior Quality Specialist, Hoffmann- La Roche Ltd

Personable, clear, concise presenter. Thoroughly enjoyed it...

Deborah Thomson, QA Coordinator, TauRx Therapeutics Ltd

Very knowledgable.

Sally Featherstone, Operations Director, Medical Device Usability Limited

Very nice and friendly. Easy to understand. I would recommend this course to colleagues who have not yet been author or co-author of new or existing SOP's .

Line Møller Kofoed , Senior Clinical Safety Associate, Novo Nordisk

Very good and interesting with plenty of real world experience to support what was being said

Chris Martin, Quality Engineer, Remote Diagnostic Technologies Ltd

Concise and very straight to the point. Great to have some with relevant proven experience delivery the course

Bolutife Adeyemi, Senior PV Associate, GW Pharmaceuticals plc

Brilliant, really enjoyed it. Given me the confidence to go ahead and write SOP's as I did find the prospect daunting and didn't know the best approach to get the job done

Diana Kalmoni-Hassay, Reports, Submissions and Compliance Associate, GW Pharmaceuticals plc

Really good course, very well organised, great speaker and very helpful group work

Holly Palmer, QA Supervisor , Torbay Pharmaceuticals

I found elements of the course particularly useful, especially the aforementioned examples of SOP format

Shaun Pope, Manager of Product Development and Operations, Mundipharma Research Ltd

Useful. Did what it said on the tin.

Sarah Naylor, Head of Quality, Upperton Ltd

The content was good, presentations and interactive way of introducing the methods

Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S

I liked the course content. However I noticed that it was not that many new ideas as I expected. Maybe because SOPs in our company seem to be written pretty well and according to the latest recommendations already.

Yvonne Wiggenhauser, Process Document Manager, Takeda Pharmaceutials International AG

It was an enjoyable course with a good mixture of taught and interactive sessions.

Sarah Soerensen, Senior clinical safety associate, Novo Nordisk A/S

Presented very well by Laura Brown. A mixture of visual and pro-active exercises was used which I found very good. Content of the course was helpful and very sufficient.

Sophie Thompson, Quality Engineer, Wesley Coe (Cambridge) Limited

Very Interactive course that give the opportunity to ask questions

Valeria Ciani, , Chiesi Farmaceutici spa