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SOP Writing and Management for Pharmaceutical Professionals

21 May 2026 | 1-Day Live Online Course

Original price was: $805.Current price is: $644.

Master the skills to write, review, and manage compliant SOPs that strengthen quality, consistency, and regulatory compliance

Register Before 17 April to Save 20% (May Course)

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Learn more about the course by toggling through the tabs below. Scroll down to view the agenda, trainer info and who should attend.

Course Overview

 

Standard Operating Procedures (SOPs) form the backbone of compliance in the pharmaceutical and biotech industries. Poorly structured or unclear SOPs can lead to inconsistent practices, data integrity concerns, and regulatory inspection findings.

 

This practical one-day course provides a step-by-step guide to writing, reviewing, and managing SOPs that meet the expectations of global regulators and align with GxP principles (GMP, GCP, GLP, and GVP). Participants will learn to use process mapping and best practice writing techniques to create SOPs that are clear, consistent, and user-friendly. Through interactive exercises, you’ll gain the confidence to produce SOPs that support compliance, quality, and operational efficiency across the product lifecycle.

 

Learn more about how we deliver live online training.

Key Learning Objectives

 

  • Understand the role of SOPs in maintaining GxP compliance in pharma and biotech.
  • Differentiate SOPs from related documents such as policies, work instructions, and forms.
  • Apply process mapping and mind mapping to structure SOPs effectively.
  • Write clear, concise, and user-focused SOPs that meet regulatory expectations.
  • Implement robust review, approval, and version-control procedures.
  • Integrate SOPs within the company’s Quality Management System (QMS).
  • Ensure SOPs withstand regulatory inspection and audit scrutiny.

What is Included in a Short Live Online Course?

 

  • Direct access to an expert trainer through interactive and engaging sessions
  • Unlimited access to session recordings for 2 weeks after the course (live format)
  • One month of unlimited access to recordings and slides (on-demand format only)
  • Validated certificate of attendance, available to download or share on LinkedIn

Course Dates

 

Find out when this course is running so you can plan your training. Scroll down to view the full agenda.

21 May 2026

1-Day Live Online Training
Register at the top of the page.

Group Discount

 

If you want to train a small group, we offer a group discount between 5% and 50% depending on the course and number of attendees.

 

For a quote, complete our contact form by following the link. Get in touch.

Customised Team Training

 

We also design and deliver fully customised team training focused on your products, processes, technologies and challenges. This is ideal for specific training requirements or larger groups. Please get in touch with us for more information.

 

For more information, complete our contact form by following the link. Get in touch.

Full Course Information and Pricing

 

  • To attend the full course, you must register online at the top of the page by selecting the course dates from the drop-down and clicking enrol to add the course to your basket. Once added, please follow the checkout instructions to pay via credit card or bank transfer.
  • There are price tiers for this course. The dates of these are located above. The earlier you register the more you save.
  • The full training course is delivered online.
  • For live online courses – The dates and times of modules/sessions are subject to change.
  • For live online courses – The module/session durations are approximate.

 

Frequently Asked Questions (FAQs)

Learn more about the course by toggling through the tabs below (Agenda, Trainer and Who Should Attend?)

Course Information

Course Information

  • The course begins at the time stated at the top of the page
  • The course is broken up into modules outlined below
  • There will be breaks between modules

21 May 2026

1-Day Live Online Training
Register at the top of the page.

Session 1

180 mins | 9:30 AM UK

Fundamentals of Effective SOPs in Pharma

  • The role of SOPs in GxP-regulated environments
  • When SOPs are required and why they matter for compliance
  • Differences between SOPs, policies, work instructions, and guidelines
  • Defining scope, ownership, and responsibilities
  • The structure of an effective SOP: sections, formatting, and clarity
  • Best practice examples from pharmaceutical QA and manufacturing
  • Who should write, review, and approve SOPs in a regulated setting

 

Writing Clear, Compliant, and User-Friendly SOPs

  • Applying process mapping to visualise workflows
  • Translating complex operations into clear procedural steps
  • Balancing technical accuracy with usability
  • Writing for the end user: tone, language, and layout considerations
  • Using templates and consistent formatting across documents

 

Exercise 1 – Drafting an SOP Section (Pharma Case Study)
Participants will write part of an SOP for a typical pharmaceutical process (e.g., deviation handling, cleaning validation, batch documentation), applying process mapping and clarity techniques.

Session 2

180 mins | 1:30 PM UK

Implementing and Managing SOPs in a Regulated Environment

  • Review and approval workflows for SOPs in pharma
  • Document control, distribution, and version management
  • Updating SOPs: when, how, and why
  • Conducting effective SOP training and ensuring user understanding
  • Monitoring SOP compliance and identifying deviations

 

Ensuring Regulatory Compliance and Audit Readiness

  • Regulatory expectations from EMA, FDA, MHRA, and WHO
  • GxP focus areas: data integrity, documentation traceability, and accountability
  • Common deficiencies identified in inspections
  • Integrating SOP management into the overall QMS

 

Exercise 2 – Review and Improve an SOP (Audit Simulation)
Participants evaluate a sample SOP for a GMP process, identify weaknesses, and propose improvements based on best practice and regulatory expectations.

 

Wrap-Up and Discussion

  • Key takeaways for improving SOP culture and compliance
  • Tools and templates for ongoing SOP development
Laura Brown

Dr Laura Brown is an independent pharmaceutical project management and training consultant and Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of managing projects in the pharmaceutical industry and has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. Laura has completed an MBA, with specialisation in project management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management and the author of two books on the subject including the leading title, Project Management for the Pharmaceutical Industry.

This course is ideal for professionals across the pharmaceutical and biotech industries who are involved in creating, reviewing, or maintaining SOPs. It is particularly valuable for those working in:

  • Quality Assurance (QA) and Quality Systems
  • Regulatory Affairs and Compliance
  • Manufacturing and Operations
  • Clinical Research and GCP Compliance
  • Pharmacovigilance and Safety
  • Laboratories and GMP Environments

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21 May 2026 | 1-Day Live Online Course

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