2023 Annual Advanced Pharmaceutical Cleaning Validation Training Program
8-Part Live Training Webinar Series
Instructor: Destin LeBlanc Biography>>>
Registration Form ►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.
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 26, 2023
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.
- Explore options to consider going forward.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Definitions and Regulatory Status,
Basis of Dose-Based Calculations,
Restrictions for Highly Hazardous Actives,
What’s in ISPE’s Risk-MaPP,
11:30 AM 10 Minute Break
What’s in EMA’s Guidance on Dedicated Facilities,
Impact of Health-based Approaches,
Suggested Approaches for Going Forward,
12:30 PMLive 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 28, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Destin LeBlanc
This live training webinar 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:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Little-discussed consequences of health-based limits,
Effects on product quality,
Effects on product purity,
Other effects,
11:30 AM 10 Minute Break
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 PMLive 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 24, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Destin LeBlanc
Cleaning Validation has traditionally focused on the 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:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Definitions of surface types,
Concerns, possible studies and validation issues for indirect product contact surfaces,
11:30 AM 10 Minute Break
Concerns, possible studies and validation issues for non-product contact surfaces,
What regulatory documents say,
12:30 PMLive 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 26, 2023
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:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Description of analytical approaches in different instruments,
Reasons for using TOC,
Setting limits based on TOC,
Use of blanks and controls,
11:30 AM 10 Minute Break
Analytical method validation,
Dealing with interferences,
Cautions in sampling and analysis,
Use of TOC throughout the validation lifecycle,
What regulatory documents say,
12:30 PMLive 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 28, 2023
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 limits 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:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Basic limit setting,
Variations based on different inputs,
Variations in defining the output,
The value of default limits,
11:30 AM 10 Minute Break
Setting limits for non-uniform transfer,
Setting limits based on stratified sampling,
What regulatory documents say about these issues,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 6: Cleaning Validation; Design and the Validation of Automated & Manual Cleaning Processes & Latest Regulatory Requirements
Live, Interactive Training Webinar
Date: Thursday November 30, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Destin LeBlanc
Thoughtful design for all stages of a lifecycle cleaning validation program is a key to success in terms of having an effective, efficient and compliant program. This live training webinar will cover various elements in Stage I work (the design of the Cleaning Process), Stage II work (the Qualification Protocol) and the Stage III work (the Validation Maintenance work), focusing on how these might be different for automated cleaning process and manual cleaning processes. For Stage I, it includes selection of cleaning methods, selection of cleaning agents, and selection of cleaning parameters (time, temperature, etc.). A focus will be the design for consistency in cleaning processes. Special qualification concerns for both manual and automated cleaning processes will be discussed. Finally, the issue of how validation maintenance might be different for the two types of cleaning processes will be covered. This live training webinar should help clarify how aspects of automated and manual cleaning processes might differ in a lifecycle approach.
Learning Benefits:
- Review the need for design in all Stages of lifecycle cleaning validation.
- Learn options for cleaning methods, cleaning agents, and cleaning process parameters.
- Explore options for manual cleaning SOPs.
- Review protocol differences between manual and automated cleaning processes.
- Learn options for validation maintenance for automated and manual cleaning processes.
- Explore approaches to address qualification protocol failures.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
The criticality of good design for cleaning processes,
11:30 AM 10 Minute Break
Design of qualification protocols,
Design of validation maintenance programs,
Addressing qualification protocol failures,
What regulatory documents say,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 7: Cleaning Validation: Visually Clean and Visual Residue Limits
Live, Interactive Training Webinar
Date: Tuesday December 12, 2023
Time: 10:30 am - 12:30 pm ET (New York Time)
Instructor: Destin LeBlanc
A need for process equipment to be visually clean at the end of a validated cleaning process has been a requirement from the beginning of regulatory guidances for cleaning validation. The idea of using a visually clean assessment as possibly being a more stringent criterion than a calculated carryover calculation was introduced in the late 1990’s by the PIC/S. As a result, there were many publications in the early 2000’s dealing with visual residue limits. Recently the EMA has presented the option of using visual residue limits (VRLs) as part of routine monitoring. This live webinar will cover defining a VRL, designing studies to determine a VRL, and using VRLs in meaningful way in qualification protocols and in routine monitoring.
Learning Benefits:
- Understand the meaning of visually clean
- Learn parameters of visual assessment.
- Understand the relationship between VRLs and calculated carryover limits.
- Learn how to determine a VRL in a lab study.
- Explore when VRLs are required (and when they are not).
- Learn how and when to use VRLs for routine monitoring.
Webinar outline and time breakdown:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Meaning of “Visually Clean”,
Parameters for visual assessment,
Different uses of a visually clean criterion,
Definition of “Visual Residue Limit”,
How to determine a VRL in the lab,
11:30 AM 10 Minute Break
How to determine a VRL in the lab (continued),
Comparing a VRL to a carryover calculation limit,
Practical options for VRL determination,
Use of VRLs in routine monitoring per EMA’s Q&A,
12:30 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
Part 8: Cleaning Validation: Dealing with Dedicated Equipment and with Campaigns
Live, Interactive Training Webinar
Date: Thursday December 14, 2023
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:
Time*
10:15 AM Log-In Period
10:30 AM Introduction
Defining dedication,
Why dedicate equipment,
Setting limits for dedicated equipment,
What regulatory documents say about dedication?,
11:30 AM 10 Minute Break
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 PMLive Questions & Discussion
*Please note all times are Eastern Time (New York Time)
This live training progra includes the following for each registered attendee:
- A copy of the presentation slides
- A certificate of participation for attendee training 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:
- Directors, Managers, Supervisors, Scientists, Technicians
- Quality Control, Quality Assurance, Manufacturing, Regulatory Affairs Personnel
- Senior Management responsible for cleaning validation
- Microbiology Personnel
How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.
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>>>