Quality Critical Cleaning and Cleaning Validation Processes

Who Should Attend?

The Quality Critical Cleaning and Cleaning Validation Processes course is intended for professionals in the development and manufacture of medical devices, pharmaceuticals, food products, and related fields. Disciplines include:

  • Research and development
  • Design/process engineering
  • Safety/environmental
  • Final assembly
  • Contract manufacturing
  • QA/validation

 

Quality

Course Description

This 15-day accredited course teaches principles and practice of Quality Critical Cleaning and Cleaning Validation in life-science applications. The emphasis is on medical devices (single use and reusable) and pharmaceutical applications. Critical product cleaning is distinct from sterilization. Failure to clean properly can pose risks in such applications as pharmaceuticals, medical devices, and food processing.

The program provides approaches to cGMPs for critical cleaning processes that integrate the factors of chemistry, equipment and process methods, and that also consider regulatory and economic issues. A successful cleaning process utilizes the 4Ds: define, develop, document, and defend. The course also addresses challenges and standards/guidance development for applications where residues are adherent or are difficult to access or detect.

Therefore, we encourage interaction during the course; and participants are encouraged to provide examples of “pain points” and nagging problems.