Overview:

Looking for online GMP training or GMP certification? This fast-track, in-depth course is ideal for those new to pharmaceutical manufacturing or switching departments. 

It builds a strong foundation in Good Manufacturing Practice (GMP), covering essential compliance topics, regulations, and quality systems, with practical insights into validation, SOPs, and risk management.

Over two intensive days, participants gain a clear understanding of GMP principles, documentation practices, regulatory expectations (MHRA, FDA, 21 CFR Part 11), and validation requirements for both the UK and global markets. 

Whether you’re pursuing a GMP certification course, enhancing your GMP training compliance, or preparing for internal/external audits, this course gives you the practical tools to succeed.

Who is it for?

• New employees (freshers) entering GMP-regulated roles

• Warehouse, production, packaging, or documentation staff requiring a fast-track foundation

• Suppliers needing to understand client GMP expectations

• Cross-functional teams (e.g. IT, HR, facilities) supporting GMP environments

• Anyone looking for a GMP certification course or structured entry-level GMP training programme

Why Choose This Course?

• Aligned with UK MHRA, FDA (21 CFR Part 11), and EU GMP (Annex 11 and 14)

• Taught by industry experts with real GMP audit experience

• Includes interactive group work, FDA case studies, and real-life warning letter analysis

• Strong foundation in SOP training, validation concepts, and risk assessment methods

• Suitable as a step toward GMP auditor certification or GMP professional certification

What’s Covered?

Day 1: GMP Fundamentals and Regulatory Foundations

• What is GMP? Understanding its purpose and history
  

• How GMP links to GLP, GCP, GDP, and GAMP
  

• Role of QA, QC, and the Qualified/Responsible Person
  

• Overview of key regulations: Orange Guide, EU Directives, FDA Code of Federal Regulations
  

• Regulatory bodies: MHRA, FDA, and how they audit and enforce
  

• Types of audits: Internal, external, FDA’s systems-based approach
  

• The 4 Ps of GMP: People, Procedures, Production, Products
  

• Warehouse GMP: FIFO, status labelling, and storage controls
  

Day 2: Documentation, Validation, and Risk Management

• Good Documentation Practices (GDP): SOP lifecycle, recordkeeping, legal compliance
  

• Validation Training: GAMP approach, validation stages (IQ, OQ, PQ), lifecycle concepts
  

• SOP Training: Writing, reviewing, and managing SOPs; avoiding common pitfalls
  

• Risk Management in GMP: ICH Q9, FMEA, and applying risk-based thinking
  

• Case Studies: Explore real GMP failures, warning letters, and audit findings
  

• Team-based exercises to solve practical GMP problems and plan improvements