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Pharmaceutical Cleaning Validation

From Key Fundamentals Through to the Most Advanced Cleaning Validation Processes, Methods and Topics Including Comprehensive Examination of the Latest FDA, EU, EMA, Health Canada and Other Regulatory Requirements & Guidelines Related to Cleaning Validation

19-Part Live Training Program

Instructor: Destin A. LeBlanc Biography>>>
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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.

Pharmaceutical manufacturers must validate their cleaning processes to ensure compliance with the latest regulatory requirements. Effective and consistent cleaning procedures must be in place and thoroughly validated to avoid cross-contamination in manufacturing and cleaning equipment. In recent years the topic of cleaning validation has received an increasing amount of attention from regulators and manufacturers seeking to solidify their processes.

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.

This instructor-led live training series is designed to provide a comprehensive review of the key pharmaceutical cleaning validation processes, best practices, technologies and the latest regulatory documents requirements including 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.

This intensive 19-part live training program on the topic of Cleaning Validation will consist of 19 live training sessions of 2 hours each. It will include almost 50 hours of live presentation and live Q&A delivered over the course of the year 2019. This method of delivery proves effective in providing trainees with ample time to take in, process, and put to use the information learned then 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 live training program’s content is a result of over thirty-five years of practical industry experience, ensuring trainees are provided with the most up to date and practical information on the topic.

This 19-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 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 Fundamentals - Robust Strategies for Designing and Improving Cleaning Validation Programs

Live, Interactive Training Webinar

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

Cleaning Validation for process equipment product contact surfaces has been a regulatory expectation since the early 1990’s. This webinar will introduce the learner to the fundamentals of cleaning validation for pharmaceutical manufacturers, including the following topics:

-Definitions and scope
-Regulatory requirements (FDA and European)
-Cleaning process consistency
-Residues and residue limits
-Analytical methods
-Sampling methods
-Protocol options and strategies
-Validation maintenance

This live training webinar is designed to provide a review of current expectations for pharmaceutical cleaning validation. Taught by one of the industry’s global leaders in cleaning validation, the attendee will be engaged in discussions that will provide robust and meaningful strategies for designing and improving their cleaning validation programs.

Learning Benefits:
-Appreciating the various parts of a cleaning validation program that must work together.
-Appropriate design of a cleaning process.
-Understanding and applying terms and concepts correctly.
-Critical elements in setting limits.
-Understanding of the latest regulatory expectations.
-Understanding selection of analytical and sampling methods.
-Integrating all elements for an effective protocol.
-Learning about worldwide regulatory expectations.

Webinar outline and time breakdown:

Date: Tuesday February 26, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions and Scope,
Regulatory Requirements,
Cleaning Process Consistency,
11:30 AM Break
11:40 AM Analytical Methods,
Sampling Methods,
Cleaning Process Challenges,
Validation Maintenance,
12:30 PM Live Questions & Discussion

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



Part 2: Designing and Implementing a Lifecycle Approach for Cleaning Validation

Live, Interactive Training Webinar

Date: Thursday February 28, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Design/development and validation maintenance has always been part of what pharmaceutical companies do for cleaning validation. Now there is an increasing trend to make a lifecycle approach part of a formal cleaning validation program. This has been accelerated by the publication of the 2011 FDA Process Validation guidance, as well as documents from other regulatory agencies and from ICH. While the FDA guidance does not formally apply to the validation of cleaning processes, other regulatory documents include cleaning processes within the purview of a lifecycle approach.

This live webinar is designed to provide an introductory review of the lifecycle principles in various regulatory documents, focusing on the FDA Process Validation Guidance. It then discusses how the principles of lifecycle validation might be applied in a cleaning validation program. It will also cover some principles typically applied in a process validation program that might not apply to a cleaning validation program. Furthermore, strategies for simplifying cleaning validation based on lifecycle principles will also be covered, including strategies to streamline cleaning validation programs based on good science and appropriate risk assessments. This includes the possibility of reducing the number of validation runs required and of moving “worst case” evaluations to the design/development phase. Application of these lifecycle principles will help provide robust and meaningful strategies for designing and improving cleaning validation programs.

Learning Benefits:
-Understanding the basics of lifecycle validation from various regulatory documents
-Learning differences and similarities of process validation and cleaning validation for lifecycle approaches
-Applying process validation lifecycle principles to cleaning validation programs in a meaningful way
-Understanding what principles or expectations for process validation do not apply and are not meaningful for cleaning validation
-Learning when to apply statistics to a cleaning validation program
-Avoiding dogma unsupported by science and logic

Webinar outline and time breakdown:

Date: Thursday February 28, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction and Applicable Regulatory Documents,
10:40 AM Stage 1 Issues (Design and Development)
Stage 2 Issues (Qualification Protocols)
11:30 AM Break
11:40 AM Stage 3 Issues (Maintenance of the Validated State),
Strategies for Incorporating Principles in Cleaning validation Programs,
Application of Statistics to Cleaning Validation,
Options for Moving to a Lifecycle Approach
12:30 PM Live Questions & Discussion

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



Part 3: Basic Limit Setting for Cleaning Validation Protocols and the Latest Regulatory Expectations

Live, Interactive Training Webinar

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

This portion of the live training program will focus on the basic issues involved in setting limits for active ingredients in cleaning validation protocols. This is often called the Maximum Allowable Carryover (MAC or MACO) calculation. Setting appropriate acceptance residue limits is a critical elements of an overall cleaning validation program. Limits are established for patient safety and product quality, but may also be set based on production efficiency. Variations on how it is presented or expressed by different companies will be presented. Specific situations in which a safety factor other than 0.001 might be used will be explored. Handling of unique situations like adult/child doses and doses based on body weight (or skin surface area) will be covered. The proper use of “default values” will be explained, as well as alternatives to use for default values. Approaches for highly hazardous actives will be covered. The regulatory basis for these approaches will be discussed.

Learning Benefits:
-Understanding the terminology applied to setting limits for cleaning validation.
-Understanding and applying limits approaches for actives in both drug product and API manufacture.
-Understanding special situations which may require modification of the basic calculations.
-Applying the use of default values.
-Understanding and applying what visually clean means.
-Learn what regulatory documents say about setting limits.

Webinar outline and time breakdown:

Date: Tuesday March 26, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Terminology and Definitions,
Basic Dose-Based Calculations,
ADE “Health-based” Limits,
Variations on How Presented,
Special Situations,
11:30 AM Break
11:40 AM Determining Protocol Compliance,
Dosing Issues,
Use of Default Values,
API Manufacture,
Regulatory Issues,
12:30 PM Live Questions & Discussion

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


Part 4: Cleaning Validation - Chemical Analytical Methods, Analytical Method Validation & Latest Regulatory Expectations

Live, Interactive Training Webinar

Date: Thursday March 28, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

This part of this live training program will focus on the issues related to chemical analytical methods and analytical method validation for cleaning validation purposes. A validated analytical method is a key part of a cleaning validation program, since it is used to establish that the cleaning process consistently is below established residue limits. Both specific and non-specific methods (including HPLC, TOC, UV and conductivity) with their advantages and limitations will be covered. Newer direct surface analytical procedures will also be described. Appropriate method validation parameters will be covered as they apply to different methods. Topics include dealing with interferences and unknown peaks, using visual examination as an analytical tool, and applications of different methods during the validation lifecycle (from design to validation maintenance). Finally, the regulatory basis for proper use of analytical methods will be discussed.

Learning Benefits:
-Understanding the terminology applied to analytical methods and their validation for cleaning validation uses.
-Understanding appropriate uses of specific and non-specific analytical methods.
-Learning how to address interferences and unknown peaks.
-Applying method validation to compendia methods.
-Utilizing visual examination as an “analytical” technique.
-Use of analytical methods during the validation lifecycle, including during design/development, qualification and continued process verification.
-Learn what regulatory documents say about analytical methods.

Webinar outline and time breakdown:

Date: Thursday March 28, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Specific vs. Non-specific Methods,
Newer Methods,
Method Use by Industry Type,
11:30 AM Break
11:40 AM Analytical Method Validation,
Dealing with Unknown Peaks,
Regulatory Issues,
12:30 PM Live Questions & Discussion

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


Part 5: Sampling Methods and Sampling Recoveries for Cleaning Validation & 2019 Regulatory Expectations

Live, Interactive Training Webinar

Date: Tuesday April 23, 2019
Time:10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Effective sampling is a key to a robust cleaning validation program. Part three of this live training program will describe the various sampling options, such as swabbing, rinsing and placebo sampling. It will cover issues related to the selection of sampling methods, including the limitations of each method. Particularly for swab sampling, parameters and practices that help achieve greater consistency in swab results will be explored, including use of multiple swabs on a given swab area. Once sampling methods are selected and designed/developed, it becomes necessary to train and/or qualify the samplers, again to assist in obtaining consistent results. Options for training and subsequent qualification of swab operators will be covered. Recovery studies for both swab and rinse sampling will be described. Issues related to the spiking parameters and conditions, as well as to the number of spiked levels for recovery studies, will be discussed. Finally, what regulatory documents say about sampling and sampling recovery will be covered.

Learning Benefits:
-Understanding the applicability of different sampling methods.
-Understanding features, benefits and limitations of different sampling methods.
-Learn how to control swab sampling for consistent results.
-Pitfalls to avoid in swab and rinse sampling.
-Designing effective and efficient recovery studies.
-How to train and qualify samplers.
-Regulatory issues in sampling.
-Handling variables such as different surfaces, areas, and limits in recovery studies.

Webinar outline and time breakdown:

Date: Tuesday April 23, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Swabbing Procedures and Swabbing Parameters,
Rinsing Procedures and Rinsing Variations,
11:30 AM Break
11:40 AM Swab Recovery Procedures,
Special Issues in Swab Recovery Studies,
Rinse Recovery Studies,
12:30 PM Live Questions & Discussion

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


Part 6: Microbiological Issues in Cleaning Validation and How to Control Bioburden

Live, Interactive Training Webinar

Date: Thursday April 25, 2019
10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Control of microorganisms by effective cleaning processes is important for both non-sterile and sterile manufacturing processes. The fourth portion of the live training program will focus on the issues involved with bioburden and other related microbiological topics for cleaning validation. It will start with a discussion of why we address microbiological issues in cleaning validation, as well as ways to control bioburden. It will then cover setting limits, sampling, and sampling recovery studies. A major focus of microbiological issues for many regulatory guidelines is prevention of bioburden proliferation following cleaning and before use. Various clean hold time issues, such as ways to minimize proliferation and to set acceptance criteria, will be addressed. Bioburden in cleaning validation is also one of the main ways that companies can leverage data from other studies based on the new FDA process validation guideline. Finally, related biological concerns, such as endotoxin, will be discussed.

Learning Benefits:
-Understanding the terminology applied to bioburden for cleaning validation.
-Learn control measures for bioburden during the cleaning process.
-Understanding and applying swab and rinse limits for bioburden, including carryover calculations and industry standard practices.
-Understanding limits determination for endotoxins based on industry standard practices.
-Understanding and applying sampling and sampling recovery studies.
-Evaluating bioburden during clean hold time studies.
-Learn what regulatory documents say about microbiological control.

Webinar outline and time breakdown:

Date: Thursday April 25, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Regulatory Guidance,
Control Measures,
Limits – Swab and Rinse,
Objectionable Organisms,
11:30 AM Break
11:40 AM Sampling and Sampling Recovery,
Clean Hold Time Issues,
Endotoxins and Viruses,
12:30 PM Live Questions & Discussion

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


Part 7: Grouping Strategies for Cleaning Validation - Using Science and Data-Driven Grouping Approaches to Effectively Accomplish Cleaning Validation & Regulatory Recommendations

Live, Interactive Training Webinar

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

Manufacturing efficiency (without compromising effectiveness and compliance) is becoming a key driver for survival and growth in the pharmaceutical and biopharmaceutical industry. One way to make cleaning validation more efficient is to use science- and data-driven grouping approaches to effectively accomplish cleaning validation.

There will be an emphasis on understanding the cleaning process, the nature of the products, and the nature of the equipment in making decisions related to grouping. In addition, issues related to the number of validation runs to perform on the representative product or equipment will be covered. Finally, regulatory support for grouping approaches will be explored.

Learning Benefits:
-Understanding the terminology applied to grouping approaches.
-Understanding and applying grouping principles to product grouping.
-How to select worst case products in a grouping approach.
-How to select limits for the worst case product.
-How to add a new product to a group.
-Understanding and applying grouping principles to equipment grouping.
-How to determine equipment equivalence and/or worst cases.
-Pitfalls to avoid in grouping approaches.
-Learn about special cases for grouping (products and equipment).
-Regulatory support for grouping approaches.

Webinar outline and time breakdown:

Date: Tuesday May 21, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions and Regulatory Status,
Product Grouping: Establishment of a New Group,
Selection of the Representative Product,
Selection of the Residue Limit for a Product Group,
11:30 AM Break
11:40 AM Special Cases for Product Grouping,
New Products for an Established Group,
Equipment Grouping,
12:30 PM Live Questions & Discussion

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


Part 8: Cleaning Validation - Maintaining Cleaning Processes in a “State of Control” & Understanding Vital Validation Maintenance Procedures

Live, Interactive Training Webinar

Date: Thursday May 23, 2019
Time:10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

Maintenance of the state of control of a previously qualified cleaning process has always been one objective of a cleaning validation program. Under a lifecycle approach to validation, it is even more critical to have a robust cleaning validation maintenance program. While in the early days of cleaning validation this often meant repeating validation protocols, there are additional options and considerations as we have learned more about adequate control. Manufacturing efficiency (without compromising effectiveness and compliance) is becoming a key driver for survival and growth in the pharmaceutical and biopharmaceutical industry. One way to make cleaning validation more efficient is to use appropriate validation maintenance practices to both reduce patient risk as well as reduce business risk due to a cleaning process that stays out of control for an extended time.

The final portion of this in depth training program will have regulatory issues related to validation maintenance discussed. Validation maintenance procedures covered include routine monitoring, preventive maintenance, change control, deviation management, retraining and revalidation. Under revalidation, both a repeat of validation protocols and a regular validation program review will be covered. There will be an emphasis on understanding the cleaning process, and the nature of the products, and the nature of the equipment in making decisions related to cleaning validation maintenance.

Learning Benefits:
-Understanding the terminology applied to validation maintenance.
-Explore different objectives between a protocol and monitoring.
-Selecting parameters for routine monitoring.
-Compare monitoring practices for automated versus manual processes.
-Learn how to conduct a regular cleaning review.
-Learn why manual cleaning processes require more attention.
-Explore how change control can be used to improve processes.
-Pitfalls to avoid in maintaining control.

Webinar outline and time breakdown:

Date: Thursday May 23, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions and Regulatory Status,
Routine monitoring,
Preventive maintenance,
Change control,
11:30 AM Break
11:40 AM Deviations,
Training and Retraining,
Re-validation,
12:30 PM Live Questions & Discussion

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


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

Part 9, Part 10 and Part 11

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 instructor-led live training segment of three sessions (Part 9, Part 10 and Part 11) 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 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

Live, Interactive Training Webinar

Date: Tuesday June 18, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

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

Live, Interactive Training Webinar

Date: Tuesday July 16, 2019
Time: 10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

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

Live, Interactive Training Webinar

Date: Tuesday August 13, 2019
Time:10:30 AM - 12:30 PM ET (New York Time)
Instructor: Destin LeBlanc

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)

Part 9, Part 10 and Part 11 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


Part 12: 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 13: 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 14: 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 15: 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 16: 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 17: 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 18: 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 19: 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 19-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

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:

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.


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>>>