Sterilization as a Benchmark for Cleaning Validation and Control

Instructor: Anthony DeMarinis
Product ID: 701278
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This Cleaning validation training will emphasize on interrelationships with other processes and using the information gained during validation to monitor and control the cleaning process to prevent failure.

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 Covered in the seminar:
  • 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 and Manufacturing Managers and Engineers who are responsible for validating cleaning or sterilization processes.
  • Consultants
  • Quality System Auditors
  • Responsible Executives

Instructor Profile:
Anthony DeMarinis, has BS degrees in Biology & Microbiology and a MS in Quality Management. He is currently Quality Systems Manager at Davol, a medical device company. He is also the Division Microbiologist responsible for sterilization and cleaning validations. Previously he was Director of Quality Assurance at Scott Laboratories and Sr. Microbiologist at the National Cancer Institute. He is a Certified Quality Auditor-BioMedical and Certified Quality Manager by the American Society for Quality. He also teaches the refresher courses for these certification programs through the local RI-ASQ section. Tony has over 20 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.

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