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How to Write Effective SOPs Training Course

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.

3 Dec 2020

& 28 Jun 2021 , 30 Jun 2021 , 2 Dec 2021 , 6 Dec 2021

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Details

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, 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.

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

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

Presenter

Laura Brown (More...)

Dr Laura Brown is an independent pharmaceutical QA consultant and the Course Director 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.

Book now

Book now

3 Dec 2020
Live webinar
3 Dec 2020
Live webinar
GBP 499.00
EUR 719.00
USD 814.00
Until 22 Oct*
Enrol now
to attend
Live webinar
28 Jun 2021
Live webinar
28 Jun 2021
Live webinar
GBP 499.00
EUR 719.00
USD 814.00
Until 17 May 21*
Enrol now
to attend
Live webinar
30 Jun 2021
Face-to-face, (venue not yet confirmed)
30 Jun 2021
Face-to-face
(venue not yet confirmed)
GBP 599.00
EUR 839.00
USD 934.00
Until 19 May 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 1 day of 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
2 Dec 2021
Live webinar
2 Dec 2021
Live webinar
GBP 499.00
EUR 719.00
USD 814.00
Until 21 Oct 21*
Enrol now
to attend
Live webinar
6 Dec 2021
Face-to-face, (venue not yet confirmed)
6 Dec 2021
Face-to-face
(venue not yet confirmed)
GBP 599.00
EUR 839.00
USD 934.00
Until 25 Oct 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 1 day of 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

Learn more about our face-to-face and webinar training formats.

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

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • ALEXION Europe SAS
  • Allergan
  • Azad Pharma AG
  • Berlin-Chemie AG
  • Bespak UK
  • CHEPLAPHARM Arzneimittel GmbH
  • Chiesi SA NV
  • Daiichi Sankyo UK Ltd
  • Eisai Ltd
  • Eli Lilly & Company Ltd
  • Evoctec Oai Ltd
  • Ferring Pharmaceuticals A/S
  • Genzyme Europe BV
  • GlaxoSmithKline Biologicals
  • H. Lundbeck A/S
  • Hospira UK Ltd
  • Laboratorios CINFA
  • Lundbeck (Ireland) Ltd
  • Neurodan A/S
  • Nutricia Ltd
  • QRC Consultants Ltd
  • Roche Products Ltd
  • Sanofi Pasteur Siege mondial
  • Servier Laboratories Ltd.
  • Sharp Life Science (EU) Ltd
  • Takeda Pharma A/S
  • Torbay Pharmaceuticals
  • Trilogy Writing & Consulting GmbH
  • UCB Pharma Limited
  • Wyeth Pharmaceuticals

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

Annette Hjemsted, PV Specialist, H. Lundbeck A/S, Dec 19

Excellent course, highly recommended.

Hannah Allende, Assistant Clinical Trials Manager, University Hospitals Plymouth NHS Trust, Dec 19

Thank you very much for the interesting course.

Nesrin Polat, Internal Audior, SOP Manager, Trilogy Writing & Consulting GmbH, Jun 19

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, Jun 19

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, Dec 18

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 18

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

Deborah Thomson, QA Coordinator, TauRx Therapeutics Ltd, Jun 18

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 18

Very knowledgable.

Sally Featherstone, Operations Director, Medical Device Usability Limited, Jun 18

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 18

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 17

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 17

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 17

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

Esther Janssen, Compliance Manager, Ferring Pharmaceuticals A/S, Dec 16

Useful. Did what it said on the tin.

Sarah Naylor, Head of Quality, Upperton Ltd, Dec 16