This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion.
Cleaning validation examples from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included.
Additional benefits of this class include:
- Learn not just from the director, but tap into the knowledge of your peers: Participants will have the opportunity to discuss their challenges and problems
- Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has several decades of pharmaceutical experience including cleaning & process validation, QA/QC, equipment qualification, analytical laboratory, R&D, and academic experience. He also teaches FDA the concepts of cleaning validation and serves as a subject matter expert (SME) for FDA litigation of companies through the Justice Department of the US government
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
Attendance at this two-day course will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel.
Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful.
By the end of this course attendees will:
- Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product
- Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections
- Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations
- Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies