Cleaning Validation


The FDA requires all companies that produce live culture cell products to comply with GMP (Good Manufacturing Practices) to mitigate risks associated with manufacturing these products. Proper cleaning of equipment used in manufacturing biopharmaceutical products is one of the most important tools to reduce product contamination and the associated risks to the public of contaminated drugs.

WPI’s Cleaning Validation program provides real-life examples and hands-on exercises to instruct participants about the regulatory requirements for cleaning, the imperatives within the cleaning life cycle, and how to assess and mitigate risks within a live culture biomanufacturing environment. This highly interactive program also provides the opportunity to discuss on-the-job cleaning challenges.

Benefits for employers and employees:

  • Learn to re-evaluate existing procedures to ensure compliance with GMP regulations
  • Improve skills for identification and correction of problems
  • Minimize equipment downtime and decrease faulty processing through enhanced cleaning techniques
  • Increase ROI and maintain competitive advantage by staying compliant and operational

Program Logistics

Key Learning Objectives

  • Understand the regulatory requirements that pertain to cleaning facilities, equipment and utensils used in the manufacturing, packaging and storing of drug products
  • Recognize the FDA, ICH, Health Canada and GMP terms likely encountered during cleaning and cleaning validation
  • Appreciate the intent of the GMP regulations as they pertain to validation
  • Comprehend the concept of the Cleaning Life Cycle and continuous improvement
  • Interpret all the standards associated with Cleaning Validation
  • Develop all of the documents needed to complete a successful cleaning validation, including the Cleaning Standard Operating procedures (SOPs), the Cleaning Validation Master Plan (CVMP), and cleaning validation protocols
  • Learn how to execute cleaning validation protocols and address deviations encountered during the execution
  • Be able to maintain the validated state through development and implementation of a Change Control/Management system, a CAPA program, and monitoring the effectiveness of the cleaning procedures

Who should attend

Any employee working in a biotechnology facility that needs training in GMP and cleaning validation, or will be moving into a field that must use GMP. This includes but is not limited to:

  • Technical services and R&D scientists involved in process/product development and implementation
  • Manufacturing and packaging personnel
  • Engineers
  • Facilities services and maintenance workers
  • Validation professionals
  • QA/QC professionals
  • Personnel responsible for GMP compliance