Overview:

The Introducing GMP Training Course serves as a foundational or refresher course ideal for individuals needing to understand the principles of Good Manufacturing Practice (GMP) within the healthcare manufacturing sector.

This course is essential for both newcomers and experienced professionals seeking to deepen their knowledge of GMP requirements and their application across various organisational aspects, including people, procedures, products, and production environments.

The course examines the application of GMP throughout companies by categorising the organisation into four main areas: People, Procedures and Documentation, Products and Components, and Production Areas and Equipment.

It also covers the regulatory environment, industry regulators, and their particular requirements in detail. This workshop seeks to improve GMP in operational settings by helping participants comprehend the repercussions of non-compliance and to develop good behaviours and habits.

The course attracts a diverse mix of learners from pharmaceutical and medical device manufacturers, wholesale distributors, and suppliers, including Original Equipment Manufacturers (OEMs).

Content:

Understand the need for GMP: Explore the critical importance of GMP in ensuring product safety, efficacy, and quality. Learn why GMP is a fundamental aspect of the healthcare manufacturing process.

What is GMP? Define Good Manufacturing Practice and understand its essential components. Learn how GMP is integral to maintaining high standards in manufacturing processes.

GMP and its link with Quality Assurance and Quality Control: Examine the relationship between GMP, Quality Assurance (QA), and Quality Control (QC). Understand how these elements work together to ensure product quality and regulatory compliance.

Define the GMP guidelines and how agencies enforce them: Review the key GMP guidelines and learn how regulatory agencies enforce compliance. Understand the specific regulations relevant to different industries.

What are the relevant regulations? Identify and explore the regulations that govern GMP practices, including those set by the FDA, EMA, and other global regulatory bodies.

How the main regulatory agencies audit and enforce them: Understand the audit and enforcement processes of major regulatory agencies. Learn what to expect during inspections and how to prepare for them.

Investigate the 4 Ps:

People: Assess the adequacy, experience, and training of personnel. Understand the roles and responsibilities of Qualified or Responsible Persons in GMP compliance.

Procedures and Documentation: Learn the importance of Standard Operating Procedures (SOPs), in-process controls, and proper documentation in maintaining GMP standards.

Production Areas and Equipment: Examine the requirements for premises, layouts, and equipment to ensure a GMP-compliant production environment.

Products and Components: Understand the handling, storage, packaging, labelling, and management of non-conforming products to maintain GMP standards.

Identify potential GMP violations and their consequences:

Learn to identify common GMP violations and understand the potential consequences of non-compliance, including regulatory actions and product recalls.

Use interactive case studies to analyse scenarios: Engage with interactive case studies to apply GMP principles in real-world scenarios, enhancing your understanding and problem-solving skills.

Examine real reported incidents: Review actual incidents reported in the industry to learn from past mistakes and understand the importance of GMP compliance.

Determine behaviours that improve GMP: Identify behaviours and practices that promote GMP compliance and improve overall operational efficiency.

Plan for workplace improvements: Develop actionable plans to implement GMP improvements in your workplace, ensuring sustained compliance and quality enhancement.

By enrolling in our GMP training programs, you will gain the essential knowledge and skills to ensure compliance with GMP standards, thereby enhancing the quality and safety of your manufacturing processes.