Advanced Cleaning Validation Training

Learn from over thirty five years of specialization in pharmaceutical cleaning validation

 

2019 Annual Advanced Pharmaceutical Cleaning Validation Training Program

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

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[Recommended for professionals seeking advanced knowledge of pharmaceutical cleaning validation processes.]

Proper cleaning and cleaning validation play a vital role in preventing patient risk by eliminating cross-contamination due to inadequate cleaning practices during the manufacturing of product. Adulterated products are often the result of ineffective cleaning processes. Following previous batches, various cleaning agents used and avoidable materials may be introduced to the product through inadequate or ineffective processes. Recently the FDA and other international governing bodies have been focusing more attention to cleaning validation process design and process maintenance as the industry is working with more intricate drug substances and complex products.

Designed for pharmaceutical professionals seeking advanced knowledge of Cleaning Validation, this intensive Annual Cleaning Validation Live Training Program will consist of 8 live advanced training sessions of 2 hours each. It will include over 20 hours of live presentation and live Q&A delivered twice a month over the course of 4 months. This method of delivery proves effective in providing trainees with ample time to take in, process, and put to use the information learned, and then to return to the next session with any questions, as opposed to condensing the intensive training program in to a short seminar saturating the audience by an early overload of information. The design and preparation of this advanced live training program’s content is a result of years of proven industry experience and knowledge, ensuring trainees are provided with the most up to date and real-world information on pharmaceutical cleaning validation.

This advanced 8-part live training program is instructed by Destin LeBlanc who has over thirty-five years of Technical Service and Product Development experience in specialty chemicals and medical technologies, the last twenty-five ten of which have been involved with various aspects of cleaning and cleaning validation in pharmaceutical and medical device manufacturing. Since 1990, he has specialized in pharmaceutical cleaning validation, and has written and lectured internationally on cleaning validation, both as part of technical symposia as well as on-site company training. He has worked with both large and small pharmaceutical companies on various aspects of cleaning and cleaning validation. He brings a unique perspective because of his expertise in effective design of cleaning processes as well as validation of those processes.

The complete course agenda detailing each individual session can be found below.

Part 1: Cleaning Validation; Utilizing “Health-Based” Limits, Toxicological Evaluation VS. Dose-Base Criterion, Examination of ISPE Approach and EMA’s New Dedication Guidance

Live, Interactive Training Webinar

Date: Tuesday September 24, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

The issue of setting limits for process equipment cleaning validation was initially settled in 1993 by reference in the FDA cleaning validation guidance to the Fourman/Mullen paper on how limits were set for drug product manufacture at Lilly. This was expanded later in the 1990’s by the PIC/S guidance regarding certain more hazardous actives. With the publication of ISPE’s Risk-MaPP (2010) and the EMA’s 2012 draft guidance on dedicated facilities, a scientific debate has been opened on appropriate ways to set limits for cleaning validation.

On one side are scientists who maintain that all limits should be based on a thorough toxicological evaluation (an ADE per Risk-MaPP or a PDE per EMA). On the other side are scientists who maintain that the dose-based criterion is more than adequate for most actives that are not highly hazardous, but that the ADE/PDE approach provides an additional option to dedicated facilities/equipment for actives which are highly hazardous. Most scientists are in the middle, unclear about what direction to go.

This live training webinar will explore the background of both the ISPE and EMA approaches, critique their suggested applications, and suggest ways to move forward.

Learning Benefits:
-Understanding the rationale for setting limits.
-Exploring how limits have been set in past.
-Differing ways to address highly hazardous and non-highly hazardous actives.
-Rationales for dedicated vs. non-dedicated facilities.
-Understand what Risk-MaPP is.
-Learn concerns about Risk-MaPP.
-Understand what EMA’s “Dedication” guidance is.
-Learn concerns about EMA’s “Dedication” guidance.
-Learn about limits based on clinical data and the TTC concept.

Webinar outline and time breakdown:

Date: Tuesday September 24, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions and Regulatory Status,
Basis of Dose-Based Calculations,
Restrictions for Highly Hazardous Actives,
11:30 AM Break
11:40 AM What’s in ISPE’s Risk-MaPP,
What’s in EMA’s Guidance on Dedicated Facilities,
Impact of Health-based Approaches,,
Suggested Approaches for Going Forward,
12:30 PM Live Questions & Discussion

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


Part 2: Utilizing “Health-Based” Limits for Cleaning Validation; Practical Considerations in Implementing “Health-Based” Limits into Protocols

Live, Interactive Training Webinar

Date: Thursday September 26, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Session 1 covers the basic definition and descriptions of “health-based” limits. Session 2 will discuss practical issues in implementing “health-based “ limits. Other concerns addressed include effects of residues on product quality and on product purity. Additional options to address these concerns will be covered. Differences between products where the primary concern is the therapeutic effect and those where the primary safety concerns are highly toxic effects other than the therapeutic effect are addressed. Numerous examples illustrating these different options will be presented. Additional alternatives to address product quality and product purity will be addressed.

This live training webinar will explore the practical implementation issues for health-based limits, and suggest ways to move forward with practical implementation.

Learning Benefits:
-Understanding pros and cons of health-based limits alone.
-Exploring other limits concerns in cleaning validation.
-Use of defaults to constrain health-based limits.
-Maintenance of dose-based limits as an alternative.
-Understand modifying health based limits based on exposure route and exposure time.
-Explore other operator, patient, and business risks for highly hazardous products.
-Explore options to consider going forward.

Webinar outline and time breakdown:

Date: Thursday September 26, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Little-discussed consequences of health-based limits,
Effects on product quality,
Effects on product purity,
Other effects,
11:30 AM Break
11:40 AM Use of defaults as a check on health-based limits,
Use of most stringent of dose-based and health-based calculations,
Health-based limits based on route of exposure,
Health-based limits based on time of exposure,
Other concerns with highly toxic drug substances,
12:30 PM Live Questions & Discussion

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


Part 3: Cleaning Validation; Dealing with “Indirect Product Contact Surfaces” and “Non-Product Contact Surfaces” & Regulatory Recommendations

Live, Interactive Training Webinar

Date: Tuesday October 22, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Cleaning Validation has traditionally focused on direct product surfaces of manufacturing equipment. Setting limits and dealing with these surfaces in cleaning validation is relatively straightforward. However, there have been increasing regulatory and industry concerns about indirect product contact surfaces (defined as a non-product contact surface that is in close proximity to open product where there is a reasonable probability of transfer of residues from that surface to the product). A newer concern, particularly for highly hazardous products, is related to residues on non-product contact surfaces. This live training webinar will focus on these two situations, exploring risks and dealing with these surfaces from a cleaning validation perspective.

Learning Benefits:
-Understand the differences among different types of surfaces.
-Explore how residues might transfer from these surfaces to manufactured product.
-Learn options for setting limits in each case.
-Learn data collection to support risk assessments.
-Explore differing ways to address highly hazardous and non-highly hazardous actives.
-Explore options to consider going forward.

Webinar outline and time breakdown:

Date: Tuesday October 22, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions of surface types,
Concerns, studies and validation issues for indirect product contact surfaces,
11:30 AM Break
11:40 AM Concerns, studies and validation issues for non-product contact surfaces,
What regulatory documents say,
12:30 PM Live Questions & Discussion

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


Part 4: Cleaning Validation; Issues in the Use of Total Organic Carbon (TOC) as an Analytical Technique

Live, Interactive Training Webinar

Date: Thursday October 24, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Total Organic Carbon (TOC) is a useful analytical method for cleaning validation studies, including design, qualification and routine monitoring. While there may be some confusion with the industry and regulatory bodies about the use of this analytical technique, it is widely used because of certain benefits. However, a key downside to TOC is that it generally makes meeting acceptance criteria more difficult. The basis of TOC as an analytical technique will be covered, involving the various technologies currently utilized. Cautions in sampling and analyses will be discussed, including the appropriate use of blank and controls

Learning Benefits:
-Understand the chemical basis of TOC analyzers.
-Learn how to set limits based on TOC.
-Learn how to validate TOC as an analytical method for cleaning validation purposes.
-Understand possible interferences from sampling and analysis.
-Learn appropriate uses of TOC throughout the validation life cycle.

Webinar outline and time breakdown:

Date: Thursday October 24, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Description of analytical approaches in different instruments,
Reasons for using TOC,
Setting limits based on TOC,
Use of blanks and controls,
11:30 AM Break
11:40 AM Analytical method validation,
Dealing with interferences,
Cautions in sampling and analysis,
Use of TOC throughout the validation lifecycle,
What regulatory documents say,
12:30 PM Live Questions & Discussion

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


Part 5: Cleaning Validation; Understanding Variations on Expression of Limits and Special Cases in Setting Residue Limits & Regulatory Concerns

Live, Interactive Training Webinar

Date: Tuesday November 19, 2019
Time:10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

While setting limits in many cases is relatively straightforward, there are options for expressing limits and/or for calculating limits that may be possible in certain situations. Variations on expressions of limits, as well as specific situations will be covered. Specific situations include stratified sampling (whereby limit are set at different surface limit values for different items in an equipment train and/or different surface types within one equipment item), placebo studies, and non-uniform transfers of residues. Conditions and constraints for such variations will be explored. .

Learning Benefits:
-Review and understand basic limit setting.
-Learn variations on basic limit setting.
-Explore stratified sampling to set limits.
-Learn where placebo sampling may be helpful.
-Learn the rationale for and ways to address non-uniform transfer.
-Learn what regulatory documents say about these techniques.

Webinar outline and time breakdown:

Date: Tuesday November 19, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Basic limit setting,
Variations based on different inputs,
Variations in defining the output,
The value of default limits,
11:30 AM Break
11:40 AM Setting limits for non-uniform transfer,
Setting limits based on stratified sampling,
What regulatory documents say about these issues,
12:30 PM Live Questions & Discussion

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


Part 6: Cleaning Validation; Design of Automated & Manual Cleaning Processes & Latest Regulatory Requirements

Live, Interactive Training Webinar

Date: Thursday November 21, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

A key to a successful cleaning validation program is designing a cleaning process which is validatable. This live training webinar will cover various elements in design work, including selection of cleaning methods, selection of cleaning agents, and selection of cleaning parameters (time, temperature, etc.). Design of equipment for automated cleaning will be explored. A special focus will be the design, control, and written procedures for manual cleaning processes. Training of operators will also be considered.

This live training webinar should help all design and/or improve both automated and manual cleaning processes.

Learning Benefits:
-Review the need for adequate design.
-Learn options for cleaning methods.
-Learn equipment design principles for both manual and automated cleaning.
-Learn features and benefits (as well as downsides) of various cleaning process parameters.
-Learn options for selection of cleaning agents.
-Explore options for manual process SOP’s and documentation.
- Consider options for training and/or qualifying manual operators

Webinar outline and time breakdown:

Date: Thursday November 21, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM The criticality of good design,
Cleaning methods,
Equipment design basics,
Cleaning parameters,
Cleaning agents,
11:30 AM Break
11:40 AM Controls in automated cleaning processes,
Options for manual cleaning processes,
Options for training and qualification,
What regulatory documents say,
12:30 PM Live Questions & Discussion

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


Part 7: Cleaning Validation: Issues in the Validation of Manual and Automated Cleaning Processes & Latest Regulatory References

Live, Interactive Training Webinar

Date: Tuesday December 10, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

In the beginning, people would discuss whether manual cleaning processes could be validated. The consensus now is that while they are more variable than automated cleaning processes, to the extent that they can be validated, they should be validated. Validation approaches for both manual and automated clean-out-of-place (COP) systems will be covered (note that there is a significant manual aspect to cleaning in an automated parts washer). For manual washing systems (brushing, wiping, etc.), the focus will be on operators’ actions, cleaning tools, documentation, training, and revalidation. For automated systems, the focus will be on appropriate load patterns and concerns about cleanliness of the cleaning equipment itself. For both, the issue of disassembly and reassembly, as well as sampling practices based on grouping (matrixing of cleaned equipment) will be covered.

Learning Benefits:
-Review the concerns about COP processes.
-Learn control elements for manual processes.
-Explore how to document disassembly and reassembly.
-Learn the importance of cleaning the manual cleaning tools and parts washers.
-Explore critical elements of equipment coverage for both manual and automated COP processes.
-Learn how to deal with the grouping (matrixing) for cleaning of small parts.
- Explore approaches to validation protocol failures

Webinar outline and time breakdown:

Date: Tuesday December 10, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Descriptions of COP processes,
Disassembly and reassembly issues,
Maintenance of manual cleaning tools,
Control elements for fully manual cleaning,
11:30 AM Break
11:40 AM Types of automated parts washers,
Key issues validation of automated parts washers,
Grouping (matrixing of small parts),
What regulatory documents say,
12:30 PM Live Questions & Discussion

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


Session 8: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns

Live, Interactive Training Webinar

Date: Thursday December 12, 2019
Time:10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Two special topics in pharmaceutical cleaning validation are cleaning for equipment dedicated to one product and cleaning for an extended campaign of the same product. Part of the confusion arises from the 1993 FDA cleaning validation guidance that discusses what is appropriate when cleaning between lots of the same product. Both of these situations should be covered in a cleaning validation program. This session will cover what is different or unique with these situations, and the various options for how they can be appropriately handled in an overall cleaning validation program.

Learning Benefits:
- Clarify what dedication means.
- Explore options for validating dedicated equipment.
- Clarify the nature of campaigns.
- Learn how to deal with “minor” cleaning within a campaign.
- Explore options for campaign length.
- Learn how regulatory documents address these issues.

Webinar outline and time breakdown:

Date: Thursday December 12, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Defining dedication,
Why dedicate equipment,
Setting limits for dedicated equipment,
What regulatory documents say about dedication?,
11:30 AM Break
11:40 AM Defining campaigns,
Determining appropriate campaign length,
Effects of “minor” cleaning in a campaign,
Special issues in campaign validation,
Extending the campaign length Training issues for operators,
What regulatory documents say about campaigns?,
12:30 PM Live Questions & Discussion

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


This comprehensive 8-Part live training program includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee training records

Who should attend:
This live training series 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 training program:

  • Senior management responsible for cleaning validation
  • Validation, Quality Control, Quality Assurance, Manufacturing, Engineering, Regulatory Affairs, Technical Support
  • Directors, Managers/Supervisors, Scientists, Technicians, Operators, Auditors
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...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

Clients: