Presented by
Management Forum

Best Practice for Writing Effective SOPs

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

2 Dec 2021 + 3 more dates

Enrol now

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

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

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 and an example of a good SOP
  • 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

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

Dr Laura Brown is an independent pharmaceutical QA consultant and the Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, Cardiff University. Laura 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

Book Best Practice for Writing Effective SOPs Live online/Classroom training

2 Dec 2021

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 11181

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 28 Oct

In your basket 

27 Jun 2022

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 11669

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 23 May

In your basket 

19 Sep 2022

Classroom
London venue TBC

09:00-17:00 UK (London)
Course code 11950

  • GBP 599 699
  • EUR 839 979
  • USD 934 1,090

Until 15 Aug

  • 1 day classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

In your basket 

12 Dec 2022

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 11794

  • GBP 499 599
  • EUR 719 859
  • USD 814 970

Until 07 Nov

In your basket 

Reviews of IPI's Best Practice for Writing Effective SOPs training course


I would recommend this webinar to other colleagues. The contents were useful for following-up the session and the speaker managed to transmit successfully her knowledge.

Dec 3 2020

Pablo Garcilópez
Regulatory Affairs Specialist, Grifols, S.A.

Dec 3 2020

Laura was clear and concise, knowledgeable and helpful. I thought that the workshops were particularly helpful.

Ben Emmett
Regulatory Affairs Executive, Bimeda Animal Health Ltd

Dec 2 2019

Excellent course, highly recommended.

Hannah Allende
Assistant Clinical Trials Manager, University Hospitals Plymouth NHS Trust

Jun 27 2019

Thank you very much for the interesting course.

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

Dec 2 2019

Excellent teacher. Laura presented in an inclusive way and her presentation kept my attention.

Annette Hjemsted
PV Specialist, H. Lundbeck A/S

Jun 27 2019

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

Dec 3 2018

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

Jun 28 2018

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

Jun 28 2018

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

Deborah Thomson
QA Coordinator, TauRx Therapeutics Ltd

Jun 28 2018

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

Jun 28 2018

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

Jun 28 2018

Very knowledgable.

Sally Featherstone
Operations Director, Medical Device Usability Limited

Dec 6 2017

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

Dec 6 2017

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

Dec 6 2017

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

Chris Martin
Quality Engineer, Remote Diagnostic Technologies Ltd

Dec 5 2016

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

Jun 30 2016

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

Dec 5 2016

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

Holly Palmer
QA Supervisor , Torbay Pharmaceuticals

Dec 5 2016

Useful. Did what it said on the tin.

Sarah Naylor
Head of Quality, Upperton Ltd

Dec 5 2016

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

Esther Janssen
Compliance Manager, Ferring Pharmaceuticals A/S

Jun 30 2016

Very Interactive course that give the opportunity to ask questions

Valeria Ciani
Chiesi Farmaceutici spa

Jun 30 2016

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

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

UK

  • 3M Healthcare Ltd
  • Abbott Laboratories Ltd
  • Advanex Europe Ltd
  • Allergan
  • Amgen Ltd
  • Animalcare
  • Animax Ltd
  • APHA
  • Aptuit (Edinburgh) Ltd
  • Associates of Cape Cod Inc
  • Astellas Pharma Europe Ltd
  • AstraZeneca UK Ltd
  • Bayer Healthcare
  • Bespak Europe Ltd
  • Bimeda Animal Health Ltd
  • Biogen Idec Ltd
  • Britannia Pharmaceuticals Ltd
  • Cambridge Consultants Ltd
  • Celgene Europe Ltd
  • CHEPLAPHARM Arzneimittel GmbH
  • Chesapeake Pharmaceutical & Healthcare Packaging
  • Chiesi
  • Daiichi Sankyo UK Ltd
  • Danisco A/S
  • Dermal Laboratories Ltd
  • DHL Hospital Logistics Centre
  • DHLSupply Chain
  • Eisai Ltd
  • Eli Lilly & Company Ltd
  • EusaPharma (Europe) Ltd
  • Evoctec Oai Ltd
  • Flynn Pharma
  • GlaxoSmithKline
  • Glenmark Pharmaceuticals Europe R&F Ltd
  • Goldenzone Ltd
  • Grunenthal Ltd
  • GSK
  • GW Pharmaceutical Ltd
  • GW Pharmaceuticals
  • GW Pharmaceuticals Ltd
  • GW Pharmaceuticals plc
  • Hologic Ltd
  • Hospira UK Ltd
  • Interport Ltd
  • Johnson & Johnson Limited
  • Magstim Company Ltd
  • MedAffairs Limited
  • Medical Device Usability Limited
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mediscribe Consulting Ltd
  • Milpharm Ltd/Aurobindo Pharma Limited
  • Moorfields Pharmaceuticals
  • MSD Ltd
  • Mundipharma Research Ltd
  • Nanopharm
  • Necessity Supplies Ltd
  • Norgine Ltd
  • Nottinghamshire Healthcare NHS Foundation Trust
  • Novus Biologicals Ltd
  • Nutricia Ltd
  • Nycomed UK Limited
  • Otsuka Pharmaceutical Europe Ltd
  • Owen Mumford Ltd
  • Panacea Pharma Projects
  • Pharmacovigilance Matters Limited
  • Pharmaspec Specials
  • Philips Respironics
  • ProductLife Limited
  • ProductLife Ltd
  • Public Health England
  • Pure Drug Safety
  • QRC Consultants Ltd
  • Rayner Intraocular Lenses Ltd
  • Reckitt Benckiser Healthcare (UK) Ltd
  • Regulis Consulting Limited
  • Remote Diagnostic Technologies Ltd
  • Roche Products Ltd
  • Sanofi Pasteur MSD Ltd
  • Servier Laboratories Ltd.
  • Sharp Life Science (EU) Ltd
  • South West London Cancer Research Network
  • Southern Salads Ltd
  • Springboard
  • Sunovion Pharmaceuticals Europe Ltd
  • TauRx Therapeutics Ltd
  • Team Consulting
  • Teva UK Ltd
  • The Binding Site Inc
  • Tissue Regenix Ltd
  • Tissue Science Laboratories PLC
  • Torbay Pharmaceuticals
  • Trac Services Ltd
  • UCB Pharma Limited
  • University Hospitals Plymouth NHS Trust
  • Upperton Ltd
  • Valeant Pharmaceuticals Ltd
  • Vetark Professional
  • Vifor Pharma UK Limited
  • Wesley Coe (Cambridge) Limited
  • Wockhart UK Limited
  • World Courier (UK) Limited
  • Wyeth Pharmaceuticals

Belgium

  • Chiesi SA NV
  • Cyberonics Europe BVBA
  • EORTC
  • GlaxoSmithKline Biologicals
  • Huvepharma NV
  • IBA
  • International Bar News
  • Ion Beam Applications SA
  • Janssen Pharmaceutica NV
  • PhaRA BV
  • s.a. Lundbeck nv
  • Sanofi-Aventis
  • SGS Belgium NV Life Science Services
  • UCB Pharma SA
  • Uteron Pharma (UPO)

Denmark

  • Actavis A/S
  • ALK
  • Copenhagen HIV Programme
  • Ferring Pharmaceuticals A/S
  • H. Lundbeck A/S
  • LEO Pharma A/S
  • Neurodan A/S
  • Novo Nordisk
  • Novo Nordisk A/S
  • Pharmacosmos A/S
  • Takeda Pharma A/S

Germany

  • AWD Pharma GmbH & Co KG
  • Bayer Healthcare AG
  • Bayer Pharma AG
  • Berlin-Chemie AG
  • Biotest AG
  • Boehringer Ingelheim Pharma GmbH & Co. KG
  • Grunenthal GmbH
  • Medac GmbH
  • MSD AH Innovation GmbH
  • Mundipharma Research GmbH & Co Kg
  • Trilogy Writing & Consulting GmbH

Italy

  • Actelion Pharmaceuticals Italia Srl
  • Alfa Wassermann S.p.A.
  • Alfrapharma Srl
  • Arcoblu srl
  • Bracco Spa
  • Bristol Myers Squibb
  • Chiesi Farmaceutici SPA
  • Di Renzo SRL
  • Diasorin S.p.A
  • Novartis Vaccines & Diagnostics SRL

Switzerland

  • Actelion Pharmaceutical Ltd
  • Azad Pharma AG
  • CYTOS Biotechnology AG
  • F. Hoffmann-La Roche Ltd
  • Hoffmann- La Roche Ltd
  • Merck Serono SA
  • Nestle Research Centre
  • Novartis Consumer Health SA
  • Skan AG
  • Takeda Pharmaceutials International AG

France

  • ALEXION Europe SAS
  • CERA SAS
  • Ceva Sante Animale Sa
  • Pierre Fabre Medicament
  • Sanofi Pasteur Siege mondial
  • Sanofi Winthrop Industrie
  • Science Union

Netherlands

  • Astellas BV
  • Beaphar BV
  • Genzyme Europe BV
  • Intervet International BV MSD Animal Health
  • Janssen Biologics BV
  • Zoetis

Spain

  • Grifols, S.A.
  • Grupo Ferrer Internacional SA
  • Laboratorios Andromaco SA
  • Laboratorios CINFA
  • Laboratorios Leti SL Unipersonal
  • Pen & Tec Consulting S.L.U.

Norway

  • Institute for Energy Technology
  • NattoPharma ASA
  • Pronova BioPharma Norge AS

Slovak Republic

  • Ewopharma International s.r.o
  • Ewopharma International s.r.o.
  • Ewopharma International, s.r.o.

Bulgaria

  • R&D Services
  • Sopharma plc

Hungary

  • EGIS Pharmaceuticals PLC
  • Mylan Hungary Kft

Ireland

  • Helsinn Birex Pharmaceuticals Ltd
  • Lundbeck (Ireland) Ltd

Israel

  • Roche (Israel) Pharmaceuticals
  • TEVA

Romania

  • Ewopharma AG
  • SC Pharma Serv International Srl

Sweden

  • Q-Med AB
  • Wellspect Healthcare

Turkey

  • Boehringer Ingelheim
  • Boehringer Ingelheim Ilaç Tic. A.S.

Australia

  • Bayer Animal Health

Canada

  • Chiesi Canada

India

  • Cipla Ltd

Lebanon

  • Grunenthal GmbH

Enrol now

Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy