An Introduction to Risk Based Compliance (GMP) for Pharmaceuticals

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Course Overview


Regulators expect that pharmaceutical professionals use risk management techniques and tools to manage product quality, manufacturing processes, validation and compliance within a risk-based Quality Management System. The ICH Q9 Guideline on Quality Risk Management is incorporated as GMP Annex 20 and Competent Authorities implement risk-based inspections.


Although an approach that has been widely used and is well established in other compliance related industry sectors, risk is still relatively new when applied to GMP. This introductory course will provide you with an overview risk-based compliance. It will illustrate how the application of risk in other areas, such as safety, can be applied to pharmaceutical manufacturing and GMP.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.


Key Learning Objectives


  • Understand the principles and practices of risk management in pharmaceutical operations
  • Learn how make sound judgements based on risk management principles
  • Understand the concept of risk based inspection
  • Learn how to utilise risk evaluation techniques to analyse pharmaceutical products, operations and systems
  • Propose control strategies and plans to mitigate unacceptable risk and loss to organizations
Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges

Topics will include

  • Principles of risk management (analysis, control and management)
  • Regulatory guidance for applying risk management in pharmaceuticals –MHRA, FDA, ICH
  • Presentation on ICH Q9 – Pharmaceutical Risk Management
  • Application of risk analysis and risk to quality management systems and CAPA systems
  • Application of risk assessment for managing product complaints
  • Application of risk analysis in compliance and auditing of pharmaceutical operations and distribution
  • Hazard Analysis and Critical Control Point (HACCP)
  • Failure Mode Effect Analysis (FMEA) in production and process control
  • Development of a Risk Management objective tree

Brian Szukala has over 30 years of industry experience and currently supports life science organisations with learning and development, performance enhancement and change management around compliance areas and topics. He has a wealth of experience in the field of compliance and has presented at numerous seminars, both in the UK and abroad on various compliance, behavioural and productivity improvement topics.


Prior to this Brian was Business Services Director at SeerPharma providing auditing, consultancy and training for the life science sector a role he took after holding the role of Head of Training at Pfizer and Abbott Laboratories in the UK.


He has been actively involved in developing competence and competency frameworks incorporated into performance management systems. He has worked with various government bodies to advise on UK skills issues within the industry and is currently on the strategic board of SEMTA (Sector Skills Council representing pharmaceuticals) advising on skills and UK competitiveness.

The course is designed to service a wide range of participants from specific disciplines within the pharmaceutical industry. Typically, participants will be managers or supervisors who have experience in a GMP related environment and have an active interest in implementing quality improvement systems.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.