2019 Advanced Pharmaceutical Cleaning Validation Training Program

A Comprehensive Review of Advanced Cleaning Validation Elements and the Most Up to Date Global Regulatory Requirements Including the Latest FDA, EU, EMA, Health Canada Regulatory Documents and Guidelines

11-Part Live Training Program

Instructor: Destin A. LeBlanc
Member Registration ►

Click Here to Register for this Live Training Program ►


Part 1: 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: 10:30am - 12:30pm ET (New York Time)

Part 2: Examining Regulatory Requirements for: Setting Limits and Analytical Methods and Method Validation
Date: Tuesday July 16, 2019 - Time: 10:30am - 12:30pm ET (New York Time)

Part 3: 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: 10:30am - 12:30pm ET (New York Time)

Part 4: 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: 10:30am - 12:30pm ET (New York Time)

Part 5: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols
Date: Thursday September 26, 2019 - Time: 10:30am - 12:30pm ET (New York Time)

Part 6: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations
Date: Tuesday October 22, 2019 - Time: 10:30am - 12:30pm ET (New York Time)

Part 7: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique
Date: Thursday October 24, 2019 - Time: 10:30am - 12:30pm ET (New York Time)

Part 8: Cleaning Validation; Understanding Variations on Expression of Limits and Special Cases in Setting Residue Limits & Regulatory Concerns
Date: Tuesday November 19, 2019 - Time: 10:30am - 12:30pm ET (New York Time)

Part 9: Cleaning Validation; Design of Automated & Manual Cleaning Processes & Latest Regulatory Requirements
Date: Thursday November 21, 2019 -Time: 10:30am - 12:30pm ET (New York Time)

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

Part 11: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Date: Thursday December 12, 2019 - Time: 10:30am - 12:30pm ET (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>>>

 

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.


Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland