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

2 Dec 2019

& 25 Jun 2020 , 3 Dec 2020

GBP 699 599 *
EUR 979 839 *
USD 1,090 934 *
* When you book before 24 Oct

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 effective SOPs.

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

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 and an example of a good SOP
  • 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 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

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

Presenters

Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

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

2 Dec 2019
2 Dec 2019 Rembrandt Hotel, London GBP 699.00
EUR 979.00
USD 1,090.00
+ VAT @ 20.00%
GBP 599.00
EUR 839.00
USD 934.00
Until 24 Oct*
Enrol now
25 Jun 2020
25 Jun 2020 Rembrandt Hotel, London
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.
3 Dec 2020
3 Dec 2020 Venue not yet confirmed
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Actavis A/S
  • Actelion Pharmaceutical Ltd
  • Arcoblu srl
  • Chiesi SA NV
  • Copenhagen HIV Programme
  • Cyberonics Europe BVBA
  • F. Hoffmann-La Roche Ltd
  • Ferring Pharmaceuticals A/S
  • Genzyme Europe BV
  • Grunenthal GmbH
  • H. Lundbeck A/S
  • Institut De Recherches Internationales Servier Iris
  • LEO Pharma A/S
  • Lundbeck (Ireland) Ltd
  • MedAffairs Limited
  • Medicines and Healthcare Regulatory Agency
  • Merck Sharp & Dohme Ltd
  • MSD Ltd
  • Nanopharm
  • Nestle Research Centre
  • Nycomed UK Limited
  • Otsuka Pharmaceutical Europe Ltd
  • Pierre Fabre Medicament
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Southern Salads Ltd
  • TEVA
  • Teva UK Ltd
  • The Binding Site
  • UCB Pharma Limited
  • Vifor Pharma UK Limited

Very interesting course, with lots of good hints and tips. Really useful with real life examples during the interactive workshops.

Mariam Salhotra, PV Assistant Manager, Pharmacovigilance - GPEL, Glenmark Pharmaceuticals Europe R&F Ltd

Thank you very much for the interesting course.

Nesrin Polat, Internal Audior, SOP Manager, Trilogy Writing & Consulting GmbH

I found the course beneficial and glad that I attended. For me personally I would have liked the course to be aimed more at GMP requirements (EU GMP Chapter 4 "documentation" wasn't even mentioned and the speaker did not know that EU GMP chapter 1 had been renamed Pharmaceutical Quality Systems from Quality Management Systems, when referencing QMS within the course. I have come away from the course with a better understanding of how to implement a more robust documentation management system. Lunch was delicious!

Hannah Throgmorton, QA Manager, Torbay Pharmaceuticals

It's one of the few courses I've done so far and it's the best of them. I do recommend it to everyone.

Margarit Poutsi, Test Technician, Team Consulting

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

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

Deborah Thomson, QA Coordinator, TauRx Therapeutics 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

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.

Sally Featherstone, Operations Director, Medical Device Usability Limited

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

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

Chris Martin, Quality Engineer, Remote Diagnostic Technologies Ltd

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

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

Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S

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

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

Holly Palmer, QA Supervisor , Torbay Pharmaceuticals

Useful. Did what it said on the tin.

Sarah Naylor, Head of Quality, Upperton Ltd

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

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