Benchmark for Cleaning Validation and Control

$299.00

Description:

Cleaning validation is increasingly important in preventing cross contamination and interactions between active ingredients in subsequent batches run in the same equipment. This webinar will review principles of sterilization validation and using them as a benchmark for more robust cleaning validation. Emphasis will also be placed on interrelationships with other processes and using the information gained during validation to monitor and control the cleaning process to prevent failure.

Areas to be Covered:

Sterilization process description and validation options including the kinetics of lethality (bioindicator vs bioburdens) and test methods
Pre-validation activities including defining worst case challenge to the process and selecting cleaning agents
Aspects to consider when writing the validation protocol
Sources of process variation and basics of process control
Data collection and troubleshooting
Post-validation (re-validation) and change control
Reporting and documentation requirements

Who will Benefit:

This webinar will benefit any organization that wants to validate and improve the effectiveness of their cleaning processes. Those who will benefit include:
QA Managers and Engineers
Manufacturing Managers and Engineers
Consultants
Quality System Auditors
Executives and Managers responsible for validating cleaning or sterilization processes

Antony J. DeMarinis

Tony DeMarinis has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently an independent Consultant specializing in Sterilization, Quality Systems, Auditing, and other Quality Management issues in the medical device and pharmaceutical industries. Previously, Tony was Director of QA/RA at Tunstall Americas for electronic monitoring devices, Quality Manager at Sealed Air for medical packaging, Quality Systems Manager at Davol for implants and surgical devices, Director of Quality Assurance at Scott Laboratories for in-vitro diagnostics and Sr. Microbiologist at the National Cancer Institute.

He is recognized as a Fellow by the American Society for Quality, and he is a Certified Quality Auditor, BioMedical Auditor, Six Sigma Black Belt, Pharmaceutical GMP Professional and Manager for Quality and Organizational Excellence. He also teaches the refresher courses for the CQA and CMQ/OE certification programs through the local ASQ sections. Tony has over 25 years’ experience using quality management techniques and value added auditing including the use of Failure Investigation and Root Cause Analysis to improve processes and products.

$299.00

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance