2019 Pharmaceutical Cleaning Validation Training Program

19-Part Live Training Program

Instructor: Destin A. LeBlanc Biography>>>
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Part 1: Cleaning Validation Fundamentals - Robust Strategies for Designing and Improving Cleaning Validation Programs
Date: Tuesday February 26, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 2: Designing and Implementing a Lifecycle Approach for Cleaning Validation
Date: Thursday February 28, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 3: Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations
Date: Tuesday March 26, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 4: Cleaning Validation - Chemical Analytical Methods, Analytical Method Validation & Latest Regulatory Expectations
Date: Thursday March 28, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 5: Sampling Methods and Sampling Recoveries for Cleaning Validation & 2019 Regulatory Expectations
Date: Tuesday April 23, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 6: Microbiological Issues in Cleaning Validation and How to Control Bioburden
Date: Thursday April 25, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 7: Grouping Strategies for Cleaning Validation - Using Science and Data-Driven Grouping Approaches to Effectively Accomplish Cleaning Validation & Regulatory Recommendations
Date: Tuesday May 21, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 8: Cleaning Validation - Maintaining Cleaning Processes in a “State of Control” & Understanding Vital Validation Maintenance Procedures
Date: Thursday May 23, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 9: Examining Regulatory Requirements for: Cleaning Validation Overview, Life Cycle Approach for Cleaning Validation, Design and Development of Cleaning Processes and Cleaning Validation Protocols and Reports
Date: Tuesday June 18, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 10: Examining Regulatory Requirements for: Setting Limits and Analytical Methods and Method Validation
Date: Tuesday July 16, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 11: Examining Regulatory Requirements for: Sampling and Sampling Recovery, Dirty Hold Time, Clean Hold Time, Microbiological Issues and Validation Maintenance
Date: Tuesday August 13, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 12: Cleaning Validation; Utilizing “Health-Based” Limits, Toxicological Evaluation VS. Dose-Base Criterion, Examination of ISPE Approach and EMA’s New Dedication Guidance
Date: Tuesday September 24, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 13: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Date: Thursday September 26, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 14: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Date: Tuesday October 22, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)br>
Part 15: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Date: Thursday October 24, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 16: Cleaning Validation; Understanding Variations on Expression of Limits and Special Cases in Setting Residue Limits & Regulatory Concerns
Date: Tuesday November 19, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 17: Cleaning Validation; Design of Automated & Manual Cleaning Processes & Latest Regulatory Requirements
Date: Thursday November 21, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 18: Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References
Date: Tuesday December 10, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Part 19: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Date: Thursday December 12, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)

Click Here to Register for this Live Training Program ►


Instructor: Destin LeBlanc

Destin LeBlanc has over twenty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last ten of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing.

Destin LeBlanc consults in the area of cleaning validation as Cleaning Validation Technologies. Previously, he had been with STERIS/Calgon Vestal for over twenty years, primarily in product development and technical service for cleaning and antimicrobial applications. He has lectured on issues related to contamination control internationally, and has written widely on cleaning validation issues. He is the author of two books Validated Cleaning Technologies for Pharmaceutical Manufacturing, Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing- Volume 1 and Cleaning Validation: Practical Compliance Solutions for... Full Bio>>>

 

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