Essential GMP Skills:​ Environmental Monitoring & Microbiological Awareness

This one-day, classroom and laboratory based, training course is hands-on and designed to ensure individuals working within GMP production facilities are well-prepared to maintain optimal aseptic conditions by compliant environmental monitoring, complying with regulatory requirements, and contributing to the safe manufacturing processes in pharmaceutical and biopharmaceutical manufacturing.

Learning objectives:

• • To explain and apply fundamental principles of GMP to ensure compliance with regulatory requirements.​
  • To describe and practice Environmental Monitoring (EM) for monitoring and controlling the manufacturing environment to prevent contamination​
  • To acquire knowledge of microbiology, including microorganism types, growth conditions, and the associated risk mitigation and the impact on product quality and safety.​
  • Understand the requirements for maintaining cleanrooms and controlled environments, including proper gowning and hygiene practices.​
  • Familiarizing self with appropriate sampling techniques and testing procedures for microbiological and particulate monitoring.​
  • Develop skills in identifying and assessing potential risks related to microbiological contamination in manufacturing processes.​
  • Understand the importance of accurate and comprehensive documentation to demonstrate compliance and traceability.​
  • Learn how to respond to deviations or non-compliance issues, and implementing corrective and preventive actions to address root causes.​
  • Ensure relevant regulatory guidelines and requirements related to environmental monitoring and microbiology in GMP settings are applied correctly.​

Who should attend:

Delegates new to highly regulated industries such as biotherapeutics, advanced therapies medicinal products (ATMPs), or pharmaceuticals, and those currently working within these sectors wishing to gain a better understanding of EM and Microbiological awareness are best suited. Appropriate for staff in Manufacturing, Quality Control (QC) and Quality Assurance (QA), personnel working in cleanrooms, validation and compliance personnel, Engineering and maintenance personnel amongst others.