cleaning validation
DESCRIPTION
Tonkin’s Cleaning Validation workshop provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The workshop 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 case studies from pharmaceutical, biologic and biopharmaceutical manufacturing processes will be included. Learning Objectives: At the end of this 2 day workshop, you will have a better understanding of: • To provide an overview and clear understanding on Cleaning Process and Cleaning Validation w.r.t Biopharmaceutical and Pharmaceutical Industry. • Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections • What to Clean and why to clean • How to develop a Cleaning Cycle • How to execute a Cleaning process • How to Sample and fix a limit for Cleaning process • How Cleaning Validation protocol to be written • How to main the Cleaning process in Validated process • Finally importance of Cleaning process w.r.t contamination and Regulatory Inspection • How to identify the Residues and fix the Limits • 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 • What are residues to be considered for Cleaning process • How to fix the limits for effective cleaning process • What is the acceptable Level or Limit for ensuring that cleaning process is satisfactory? Visually clean, LTD, MDD, 10ppm, MACO, NOEL and other criteria • Best Practices for risk assessment and justification of cleaning targets and residue limits • Different Sampling Techniques for Cleaning Validation • Microbial Issues to be considered in cleaning Validation • Cleaning Validation protocols development and Cleaning Validation strategies • How to maintain the Cleaning process under Validated status Course Director: Umesh Baikunje Sr. General Manager - Quality and Regulatory Affairs StempeuticsTRANSCRIPT
