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2019 Pharmaceutical Cleaning Validation Regulatory Compliance Training Program

A Comprehensive Review of the Latest FDA, EU, EMA, Health Canada Regulatory Documents and Guidelines

3-Part Live Training Program
Instructor: Destin A. LeBlanc Biography>>>

Member Registration ►

Click Here to Register for this Live Training Program ►


Knowing what regulatory documents say, and what they don’t say, is critical to the design, execution and maintenance of a defendable cleaning validation program. It is sometimes easy to be lead into thinking that regulatory documents specify some practices that they really don’t, or even worse, to not be aware of key items where regulatory documents do provide specific guidance.

This comprehensive live instructor-led training series of three sessions is designed to provide a comprehensive review of selected regulatory documents as they relate to cleaning validation. The approach involves discussing key cleaning validation topics and presenting what regulatory documents state about that topic. In addition to presenting what regulatory documents actually say, additional perspectives on the application of those regulatory statements will be given.

The main regulatory documents covered include US and EU GMPs, USA guidance documents (both Level 1 and Level 2 documents), EMA guidelines (including EMA “Q&A” documents), Health Canada guidelines, PIC/S recommendations, and ICH guidelines (including ICH “Q&A” documents). Other regulatory documents will be covered to address special concerns. Only regulatory documents will be covered; excluded are industry guidelines, such as from PDA, ISPE, and APIC.

Specific topics covered will be as follows:

Part 1 - Tuesday June 18, 2019

Examining regulatory requirements for:
• Cleaning Validation Overview
• Life Cycle Approach for Cleaning Validation
• Design and Development of Cleaning Processes
• Cleaning Validation Protocols and Reports

Webinar outline and time breakdown:
Time*
10:15 AM     Log In Period
10:30 AM     Cleaning Validation Overview
                     Life Cycle Approach for Cleaning Validation
11:30 AM     Break
11:40 AM     Design and Development of Cleaning Processes
                    Cleaning Validation Protocols and Reports
12:30 PM     Live Questions & Discussion


Part 2 - Tuesday July 16, 2019

Examining regulatory requirements for:
• Setting Limits
• Analytical Methods and Method Validation

Webinar outline and time breakdown:
Time*
10:15 AM     Log In Period
10:30 AM     Setting Limits
11:30 AM     Break
11:40 AM     Setting Limits (continued)
                     Analytical Methods and Method Validation
12:30 PM     Live Questions & Discussion


Part 3 – Tuesday August 13, 2019

Examining regulatory requirements for:
• Sampling and Sampling Recovery
• Dirty Hold Time
• Clean Hold Time
• Microbiological Issues
• Validation Maintenance

Webinar outline and time breakdown:
Time*
10:15 AM     Log In Period
10:30 AM     Sampling and Sampling Recovery
                     Dirty Hold Time
11:30 AM     Break
11:40 AM     Clean Hold Time
                     Microbiological Issues
                     Validation Maintenance
                     Other Issues
12:30 PM     Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

3-Part Live Training Program Learning Benefits:

-Understanding the specific wording of various regulatory documents
- US and EU GMPs, USA guidance documents (both Level 1 and Level 2 documents), EMA guidelines (including EMA “Q&A” documents), Health Canada guidelines, PIC/S recommendations, and ICH guidelines (including ICH “Q&A” documents)
-Learning how specific guideline statements might be appropriately applied
-Using guideline statements to support specific practices
-Avoiding general “cookie cutter” approaches unsupported by science and logic

Each session will focus on the content and applicability of various statements in regulatory documents

This live training webinar includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of training for attendee records

Who should attend:

This live training webinar is applicable to drug product manufacturers and API manufacturers, including biopharmaceutical manufacturers. The following individuals or disciplines involved in process equipment cleaning validation will benefit from attending this live webinar:
• Senior management responsible for cleaning validation
• Validation, Quality Control, Quality Assurance
• Manufacturing, Engineering, Technical Support
• Microbiology personnel
• Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
• Regulatory Affairs Professionals

Click Here to Register for this Live Training Program ►

 
A comprehensive review of select regulatory documents as they relate specifically to cleaning validation. Training on the regulations critical to the design, execution and maintenance of a defendable cleaning validation program. Focused on key items where regulatory documents do provide specific guidance. This opportunity is a must take for all drug product manufacturers, API manufacturers, and biopharmaceutical manufacturers.

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

Clients:

 

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...Full Bio>>>