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2019 United States Pharmacopeia (USP) Microbiological General and Information Chapters Training Program

9-Part Live Training Program
Instructor: Barry A. Friedman Ph.D. Biography>>>

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The United States Pharmacopeia (USP) contains a number of chapters relating to microbiology within its General and General Information Chapters. These Chapters present information that relate to both non-sterile and aseptic processing. Several of these chapters have been recently updated and all have been updated since 2009. Each of these Chapters has relevance to each other and provides a significant knowledge base of microbiological requirements. Several of these have also been harmonized and permit one to not only follow the USP, but simultaneously meet the requirements of both the European and Japanese Pharmacopeia.

This intensive annual live training program on the topic of USP Microbiological General and Information Chapters will consist of 9 live training sessions of 2-hour presentation time followed by 30 minutes of live Q&A each. It will include over 22 hours of live presentation and Q&A delivered periodically over the course of several months. The method of delivery proves effective in providing trainees with ample time to absorb, process, and put to use the information learned, and then return to the next session with any questions, as opposed to condensing this intensive training program’s curriculum into a short seminar, and thereby saturating the audience with an overload of information.

The design and preparation of this program’s content is a result of years of practical industry experience on the part of the presenter, Dr. Friedman, ensuring that trainees will be provided with the most up to date and practical information on the topic.

This multi-part live training program is instructed by Dr. Barry Friedman, who has over thirty years of experience in pharmaceuticals, biotechnology and regulatory compliance. He has worked with both large and small pharmaceutical and biotechnology companies on various aspects of non-sterile and sterile microbiology to include auditing, method validation and regulatory compliance.

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

Part 1 - USP <61>/<62> Microbiological Enumeration & Examination of Non-Sterile Products – Understanding the Current Standards for the New USP and Harmonized EP Microorganisms

Live, Interactive Training Webinar

Date: Tuesday March 5, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

In May 2009 the United States Pharmacopeia (USP), revision 32, implemented the long-awaited separation of USP General Chapter <61> Microbial Limit Tests into two new chapters, i.e., USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration, and USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.

As part of these two new chapters, USP <61> and USP <62>, changes were made within the areas of sampling, quantities of final product required for testing and the media to be used for this testing. In addition, acceptance criteria have changed when recording acceptable microbiological results.

The monograph for non-sterile products reference this test, e.g., USP <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP <61> and <62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing.

Alternative automated and rapid microbiological test methods, which may be utilized in lieu of the USP pharmacopeial method, will also be examined as part of USP <61>/<62> and examples provided.

The objective of this live, interactive webinar is to explore the changes to this historic USP test method, compare it to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.

Learning Benefits:
-Understanding the regulatory expectations for the new USP <61>/<62> and harmonized EP
-Alternatives to using USP <62>
-Requirements for sampling
-Media to use for testing
-Acceptance criteria required to meet microbiological specifications
-Improving process reliability, product safety and reliability
-Examine how case studies may provide improvement suggestions within your organization

Webinar outline and time breakdown:

Date: Tuesday March 5, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Establishing Microbiological Analytical Procedures and Acceptance Limits,
Types of Microbiological Methods,
Meeting FDA, USP and EP Requirements for Microbiological Examination of Nonsterile Products,
Meeting USP <61> Requirement for Microbiological Testing
11:30 AM Break
11:40 AM Meeting USP <61> Requirement for Microbiological Testing (con't),
Meeting USP <62> Requirement for Microbiological Testing,
12:30 PM Live Questions & Discussion

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


Part 2: USP <1111> Microbiological Examination of Non-Sterile Products; Controlling Microbial Contamination in Pharmaceutical/Biotech Non-Sterile & Sterile Manufacturing and the New Regulatory Attitude

Live, Interactive Training Webinar

Date: Thursday March 7, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

Microbial contamination within the pharmaceutical/biotechnology environment is a continuing challenge to the industry. With regulations continuing to become more stringent, various regulatory agencies have gained more "teeth" within their enforcement arms. With more and more large proteinaceous molecules evolving within the market place, aseptic filling has assumed more prominence and more of a role that requires control.

Non-sterile manufacturing involves issues and challenges many times overlooked in aseptic operations. These include the handling and evaluating of non-sterile components, environments and products. The monographs for non-sterile products references this test, e.g., USP <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP <61> and <62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing.

This interactive live training webinar discusses various issues with non-sterile manufacturing to include: 1) establishing microbiological analytical procedures and acceptance specifications, 2) setting of specifications, 3) process development, 4) preservation, 5) holding times, 6) cleaning, 7) sanitization, and 8) approaches to evaluating recovered organisms. It will address how one determines what a “specified” or “objectionable” microorganism is based on USP<1111> and USP<62>. It will also discuss methods for enumeration of these microorganisms and why microbiological examination of the in-coming materials and the manufacturing process are critical to eliminating potential recall issues regardless of the finished product's non-sterile status.

This live and interactive webinar is for pharmaceutical, cosmetic and other industries that produce product labeled as non-sterile. Those in both decision and non-decision-making capacities will benefit from this presentation.

Learning Benefits:
-Discuss key issues with microbiological control in manufacturing non-sterile products
-Identify the regulatory concerns in non-sterile manufacturing
-Review of an established non-sterile microbiological control program
-Identify gaps within current regulatory and industry expectations
-Examine the new regulatory “attitude” that is being taken with non-sterile products
-Explore Form FDA 483s and Warning Letters that have recently been issued and their relationship to microbial contamination

Webinar outline and time breakdown:

Date: Thursday March 7, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Discuss key issues with Microbiological Control in Manufacturing Non-Sterile Products Expand key issues to include:

1) establishing microbiological analytical procedures and acceptance specifications,
2) setting of specifications,
3) process development,
4) preservation,
5) holding times,
6) cleaning,
7) sanitization,
8) approaches to evaluating recovered organisms
11:30 AM Break
11:40 AM Identify the regulatory concerns in Non-Sterile Manufacturing
Microbiological Attributes of Non-Sterile Pharmaceutical Products
Form FDA 483s and Warning Letters
12:30 PM Live Questions & Discussion

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


Part 3: USP <1115> Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter

Live, Interactive Training Webinar

Date: Tuesday April 2, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

USP recently released a new document describing bioburden control of non-sterile drug substances and products -- a much anticipated area that has gained significant attention over the past half dozen years. The subject, "USP <1115> Bioburden Control of Nonsterile Drug Substances and Products", has generated much controversy as nonsterile manufacturers have repeatedly asked the question "what degree of microbial cleanliness should I require with my nonsterile drug substances and products" and "how many microorganisms of a single genus may I have where USP<1111> has limits of either 100 or 1000 per gram"? Efforts have been made to historically determine these questions within other USP Chapters to include USP<61>, USP<1111> and USP<1231> which have addressed both test methodologies and microbial counts allowed. 21 CFR 211 has also "weighed into" this fray with their various regulations, but have not offered solutions. Quite often during lectures and seminars, the comment is overheard "With sterile products, it was so much simpler to provide a microbial answer because I have definitive endpoints".

This new USP General Information Chapter approaches nonsterile drug substance and bioburden control from a Risk Management perspective (ICH Q9). It compares considerations of excessive cost and complexity vs. added value to the consumer and the product. The document also provides microbial control considerations in an array of microbiological control areas to include manufacturing, equipment design, personnel and the overall management of a nonsterile microbiological control program.

The objective of this live, PharmaWebinar is to review this new document and consider how a risk-based approach to the control of potential contamination in nonsterile product manufacturing may assist your organization. Plan to bring a multi-functional group to this webinar to gain the most from this new USP General Information Chapter.

Learning Benefits:
-Overall Management of a Microbiological Control Program.
-Microbial Assessment of Nonsterile Product Manufacturing Environments.
-Microbial Control Considerations During Product Development.
-Microbial Control Considerations During Manufacturing.
-Microbial Control of Drug Substance Manufacturing.

Webinar outline and time breakdown:

Date: Tuesday April 2, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Overall Management of a Microbiological Control Program,
Microbial Assessment of Nonsterile Product Manufacturing Environments,
Microbial Control Considerations During Product Development,
11:30 AM Break
11:40 AM Examine the Bases for the Bacterial Endotoxin Tests,
Microbial Control Considerations During Manufacturing,
Microbial Control of Drug Substance Manufacturing,
Warning Letter Examples,
12:30 PM Live Questions & Discussion

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


Part 4: USP <51> Antimicrobial Effectiveness Testing – A New 2016 Revised Chapter

Live, Interactive Training Webinar

Date: Thursday April 4, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

On May 1, 2016 the United States Pharmacopeia revised USP<51> Antimicrobial Effectiveness Testing, USP 36 to permit it to become better aligned with various other USP General Chapters that were previously modified. These Chapters included USP<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests; USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms; and USP<71> Sterility Tests.

This new revision provides to the user greater clarity in preparation and use of test microorganisms, which test microorganisms should be used and when, how to perform growth promotion testing, and method suitability (bacteriostasis/fungistasis). The revision also clarifies the definition of “no increase” and method execution.

As part of this live webinar, the newly revised USP <51> will also be compared and contracted to the European Pharmacopeia, EU 5.1.3 Efficacy of Antimicrobial Preservation.

The objective of this live training webinar is to explore the role of the changes of antimicrobial effectiveness testing and assuring that manufactured product will retain its effectiveness of maintaining either low number or no microorganisms within product as prescribed by GMPs. It will review the issues regarding standardized and house microorganisms, management of Type 1 through Type 4 products and the interactions that occur between USP and EU testing. Because of the sensitivity of the antimicrobials with nonsterile product, this live training webinar is a MUST for anyone in your organization that is involved with nonsterile product.

Learning Benefits:
-Understand why Antimicrobial Preservatives are often Required for Aqueous Pharmaceutical Products.
-Learn about Controls to include Growth Promotion and Method Suitability (bacteriostasis/fungistasis).
-Gain an Understanding of the Method Itself.
-Learn why USP<51> may not Meet European Pharmacopeia Standards.
-Review Case Studies of specific Warning Letters.

Webinar outline and time breakdown:
Date: Thursday April 4, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Learn why Antimicrobial Preservatives are often Required for Aqueous Pharmaceutical Products,
Understand the Growth Promotion and Suitability of the Recovery Methods Studies,
Learn what Strains May be Used as Well as the Preparation of the Strains,
Learn about the Four Product Categories,
11:30 AM Break
11:40 AM Determine the Concentration of Each Microorganism and Its Conditions for Growth,
Learn of the Criteria for Antimicrobial Effectiveness,
A Comparison of the Proposed USP Revised Method vs. the Current EU Method,
Warning Letters –Examples of Non-Conformance,
12:30 PM Live Questions & Discussion

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


Part 5: The USP <1113> Microbial Characterization, Identification, and Strain Typing. What it Means to cGMP; Exploring Various Available Methodologies to Characterize and Identify Microorganisms

Live, Interactive Training Webinar

Date: Tuesday April 30, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

The identification of microorganisms is a key element in defining the root cause of a sterility test failure or determining the source of any on-going microbiological investigation. A variety of Guidances, Regulations and Testing Standards recognize the importance of obtaining the microorganism's identity. FDA's Guidance for Industry on Aseptic Processing speaks to the criticality of using genotypic microbial identification methods, 21 CFR §211.113 speaks to the issue of microbiological contamination control, USP General Chapters <62> and <71> discuss identification of microorganisms and the allowance for the invalidation of the sterility test, respectively. USP General Information Chapter <1111> describes what constitutes a "specified" microorganism for non-sterile product.

Microbial identification is an important component of processes that exceed Alert or Action Levels, contain "specified" microorganisms, cause Out of Trend (OOT), create failures within Sterility Tests and contribute to other product failures.

The monographs for non-sterile products references this test, e.g., USP <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In addition, USP <61> and <62> form the basis for many other USP General Chapter tests to include bioburden, antimicrobial effectiveness, environmental and utilities testing.

This live training webinar will examine a variety of the issues surrounding microbial characterization and identification to include 1) when is a Gram stain sufficient, 2) when is a Genus identification sufficient, and 3) when must a species or strain identification be obtained. This presentation will review both phenotypic and genotypic methods available and what is considered the "Gold Standard" of identification. It will discuss why the FDA believes an on-site microbiologist is an asset to an organization that is releasing both non-sterile and sterile product.

The objective of this live training webinar is to explore various methodologies that are available to characterize and identify microorganisms and assist in determining what may be the appropriate method(s) for use in your facilities based on your organizational requirements and the level of microbiological training and experience that exist within your organization.

Learning Benefits:
-How to develop an overall strategy for determining how extensive an identification may be required.
-When a pure culture is and is not required for analysis <62>.
-The consequences of attempting to isolated microorganisms with a contaminated culture.
-Easy information to obtain using Phenotypic Characteristics.
-What Bergey's Manual of Systematic Bacteriology uses for taxonomic classification.
-Advantages/disadvantages of using Phenotypic methods.
-Advantages/disadvantages of using Genotypic methods.
-Verification of microbial identification methods.
-Review Warning Letters related to microbial identification issues.

Webinar outline and time breakdown:
Date: Tuesday April 30, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Developing an Overall Strategy,
Requirements for Microbial Analyses,
Requirements for Microbial Analyses,
11:30 AM Break
11:40 AM Phenotypic vs. Genotypic Analyses,
Warning Letters - Microbial Identification Issues,
12:30 PM Live Questions & Discussion

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


Part 6: USP <1072> Disinfectants and Antiseptics - Use and Application of Sanitizers, Disinfectants and Sterilants

Live, Interactive Training Webinar

Date: Thursday May 2, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

Microbiology plays a role throughout the manufacture of pharmaceutical products. Both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process and may include the raw materials and in-process operation through final product. The environmental and utility systems must also be maintained as must the packaging components, manufacturing equipment, and personnel. To maintain this controlled process and environment, sanitizers, disinfectants and sterilants (sporicides) are essential.

To assist with maintaining this controlled environment also requires knowledge of the microorganisms present and their susceptibility to various sanitizers, disinfectants and sterilants. Whether the final product is non-sterile or sterile, the bioburden exists throughout the process and/or within the product's environment. A critical review of the overall microbiological process will determine whether the critical “in-process” points permit the final product to meet its acceptance criteria. USP<1072> Disinfectants and Antiseptics, a General Information Chapter, is a useful tool which assists the user in the maintenance of this controlled process.

The determination of the disinfectant to use is largely dependent upon the site of application and the type of microorganism present. For example, Gram positive cocci are very easy to kill, while spore forming rods and fungi are more resistant. Other elements that need to be considered include the biocidal activity, concentration of microorganisms, contact time, and secondary issues to include water hardness and organic materials. In addition, surface films may also interfere with the direct contact of the microorganism and the disinfecting agent. Any "objectionable" or "specified" microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Whether you are auditing a raw material supplier, a testing laboratory, or your own facilities, you should be aware of the critical role the microorganisms play throughout. You should be aware of the various microbiological related documents, e.g., raw material sampling criteria, in-process, API, final product, environmental and utilities, to determine whether the SOPs, validations as well as government and other regulatory body documents are maintaining the control required to permit the final product to enter the marketplace as microbiologically safe.

The objective of this live training webinar is to explore the use of various sanitizers, disinfectants and sterilants within a controlled environment and learn which materials may be appropriate for your facilities’ operations and to assure that you are complying with your own SOPs, governmental and regulatory guidances and regulations. USP<1072> Disinfectants and Antiseptics, a General Information Chapter, is a useful tool which will assist the user in the maintenance of this controlled process.

Learning Benefits:
-The FDA’s view on disinfection. -The spectrum of disinfection. -The effectiveness of differing types of sanitizers, disinfectants and sterilants on a microbiological population as per USP<1072>.
-How Microbial Enumeration (USP<61>, <62>) impacts all microbiological issues.
-Microbiological identification and its application in choosing the correct disinfectant/sterilant.
-Testing requirements within a disinfection program.
-Microorganisms to include within a disinfection testing program.

Webinar outline and time breakdown:
Date: Thursday May 2, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Several FDA related Disinfection Issues,
The Choosing of an Acceptable Sanitizer, Disinfectant or Sterilant (Sporicide),
Microbial Identification and the Choosing of the Proper Disinfectant,
Why a “Complete” Identification is not Always Required in Selecting a Disinfectant,
Proper Application of a Sanitizer, Disinfectant or Sterilant,
11:30 AM Break
11:40 AM Myths Surrounding Resistance to Disinfectants,
Why a “Complete” Identification is not Always Required in Selecting a Disinfectant,
Which Government Body Regulates Disinfectants,
Microorganisms to Include in Disinfection Testing,
12:30 PM Live Questions & Discussion

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


Part 7: USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments and Its Comparison & Contrast to FDA’s Guidance; Aseptic Processing (2004) and Annex 1 (2009)

Live, Interactive Training Webinar

Date: Tuesday May 28, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.

In May 2012 the United States Pharmacopeia (USP), Rev. 35, implemented the long awaited revision of USP General Information Chapter <1116> Microbiological Control and Monitoring of Aseptic Processing Environments.

This Chapter provides information and recommendations for environments where the risk of microbial contamination is controlled by aseptic processing. It further discusses the importance of a microbiological evaluation program for controlled environments. These areas will be compared and contrasted to FDA's Guidance for Industry re: Sterile Drug Products Produced by Aseptic Processing (2004) and EMA's Annex 1 (2009).

Various changes will also be discussed. Within the revised USP<1116>, microorganisms within the ISO CLASS 5, 6, 7 and 8 areas lose some of their historic emphasis on Alert and Action Levels and reflect trending -- especially in the ISO CLASS 5 and 6 areas. People recognize that it is not possible to maintain a "sterile" Aseptic Processing Area (APA) and wherever people are present, microbial contamination will also be there. Because the current thinking emphasizes trends, USP<1116> allows for the possibility of single plate contamination levels as high as 15 CFU (Out of Trend) , but quickly states should this occur, an investigation will be required. This leads to a Table that discusses frequencies which "back into" the other two accepted methodologies (FDA and EMA, see above).

The objective of this live training webinar is to review this revised document and explore changes to this revised USP Information Chapter, compare and contrast it to FDA's Guidance for Industry, Aseptic Processing (2004) and Annex 1 (2009) and how it impacts the typical Aseptic Processing Area.

Learning Benefits:
-Understanding the regulatory expectations for the revised USP <1116> .
-Integrating USP<1116> with FDA's Aseptic Processing Guidance and Annex 1.
-What the new "Suggested Initial Contamination Recovery Rates" mean to you.
-What happens when one has significant excursions .
-Acceptance criteria required to meet microbiological Clean Room specifications.
-The impact on the identification of microbial isolates .

Webinar outline and time breakdown:
Tuesday May 28, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Reviewing the background of revised USP <1116>,
Understanding the regulatory expectations for the revised USP<1116>,
Integrating USP <1116> with FDA's Aseptic Processing Guidance & Annex 1,
How to manage "significant" excursions,
11:30 AM Break
11:40 AM Trending within the various ISO CLASS environments,
Is microbial identification still required,
12:30 PM Live Questions & Discussion

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


Part 8: USP <71> Sterility Tests; Method, Limitations, Sampling Quantities and Volumes to Conform with United States Pharmacopoeia

Live, Interactive Training Webinar

Date: Thursday May 30, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A.Friedman Ph.D.


USP<71> Sterility Tests represents the "Gold Standard" for sterility testing. Together with both the European Pharmacopeia (EP 2.6.1 Sterility) and the Japanese Pharmacopeia (JP 4.06 Sterility Test), they represent a 90+% harmonized test method that is utilized to determine the sterility of a product.

A variety of issues with USP <71> make it a difficult test to understand, develop and follow within one’s laboratory. Everything from Growth Promotion testing of the media to assuring no inhibition/enhancement (I/E) of the product to be tested requires the knowledge and assurance that the test is being completed as required. In addition, the number of units necessary for testing, the total volume required for the test and assurance that the media is providing accurate results all become important aspects of assuring the test is performed properly and the final result meet those specifications. Finally, correct interpretation of the results and the proper procedures to use should a failure occur require a thorough knowledge of USP <71>. Any failure of a Sterility Test will also cause one to potentially review all of the elements within the media fills or terminal sterilization validation that were involved in developing the process that would provide the final, sterile end product.

A failure of a Sterility Test (whether an accurate result or not), will result in an investigation to determine the “root cause” of the failure. Even if that “root cause” is determined, management will quite often determine, in the current regulatory environment, to scrap the product, rather than second guess the regulatory agencies that will periodically audit them. With sterility testing being an exacting procedure, and assurance of asepsis essential, it is important that personnel be properly trained and qualified.

The test for sterility is performed under aseptic conditions within an ISO Class 5 hood or within an ISO Class 5 Isolator. Precautions are required to assure that neither microorganisms from the individual testing or the environment contaminate the product being tested. The working condition of the area in which the test is performed should be monitored regularly by appropriate sampling of the working area and by using appropriate aseptic methods to provide control. Each of these areas will be discussed in detail.

The objective of this live training webinar is to obtain an enhanced understanding of USP <71> Sterility Tests, its inherent method, limitations, sampling quantities and volumes to assure that the test is being applied as appropriate per United States Pharmacopeia and how to interpret the final result, regardless of whether it represents a pass or a failure. Review of Case Studies/Warning Letters will also be reviewed to further explain this document.

Learning Benefits:
-Methods of sterility testing. -Review of the appropriate media to use for sterility testing.
-Determination of the quantity of each article for testing and why.
-Review of number of items for each medium and why.
-How to select the appropriate technique for testing.
-Use of diluents with sterility testing.
-Interpretation of the results – regardless of a pass or failure.
-Review of pertinent Warning Letters.

Webinar outline and time breakdown:
Date: Thursday May 30, 2019

Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Test Background, Methods of Sterility Testing, Media Used,
Articles and Number Required for Testing, Growth Promotion and I/E Testing,
11:30 AM Break
11:40 AM Time Frame Related to Testing including Other Assays Historically Used,
Choosing the Appropriate Method, Training the Personnel,
Interpreting the Results of a Sterility Pass or Failure,
Review of Pertinent Case Studies/Warning Letters,
12:30 PM Live Questions & Discussion

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


Part 9: FDA New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices; A Comprehensive Review of the Current Testing Requirements to Include USP <85> Bacterial Endotoxins Test & The USP Microbiology Expert Committee’s Opinion on Low Endotoxin Recovery (LER)

Live, Interactive Training Webinar

Date: Tuesday June 25, 2019
Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Barry A. Friedman Ph.D.


The FDA posted on their web site on Tuesday, July 12, 2011 a notice that they had withdrawn the 1987 Guideline on Validation of the Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human Parenteral Drugs, Biological Products and Medical Devices. They advised that the 1987 Guideline is considered obsolete and does not reflect the Agency's current thinking on the topic. In lieu of this document, the FDA advised that they would be issuing a Guidance for Industry on Pyrogen and Endotoxins Testing: Questions and Answers during the November/ December 2011 timeframe. After much delay, this NEW Guidance was released in June 2012. The EP also revised their guidance document 5.1.10 Guidelines for Using the Test for Bacterial Endotoxins (Oct 2014).

The FDA referenced, however, three documents that they believe have more than offset the previous FDA Guidance that was withdrawn. They advise that these documents be referenced for the fundamental principles of the gel clot, photometric and kinetic test methods. This NEW, revised Guidance supplements the above three documents and addresses those issues that may be subject to misinterpretation, not covered in compendial procedures or in the previously available Guidance document. The EP General Chapter 5.1.10 has undergone several revisions to include 1) endotoxin limits for specific substances or product, 2) the use of 2.6.30 Monocyte Activation Test as an alternative to rabbit pyrogen, 3) limiting the Rabbit Pyrogen test, and 4) the use of Recombinant Factor C.

Low Endotoxin Recovery has recently dominated endotoxin discussions since this was observed within a monoclonal antibody formulation in 2013. The USP Microbiology Expert Committee has remained interested in this subject and in 2016 provided their opinion after extensive peer and regulatory reviews. This subject, along with the various Endotoxin Test Guidances will be presented during this interactive, live training webinar.

The objective of this live training webinar is to explore the NEW/REVISED Guidances for Industry on Pyrogen and Endotoxins Testing which addresses those issues that may be subject to misinterpretation, and are not covered in compendial procedures or in the currently available Guidance documents and how they impact testing within the typical Quality Control laboratory. Examples of FDA Warning Letters which illustrate problems associated with endotoxin will also be provided. It will also discuss the issue of LER and the conclusions reached by the USP Microbiological Expert Committee.

Learning Benefits:
-Provide a review of the current testing requirements.
-Understanding what happened to the old 87/91 LAL Guidance for Industry document.
-Learn what has replaced it and why.
-Learn of common issue misunderstandings and misinterpretations.
-Determine who comprised the Agency Guidance team involved within this new proposed Guidance.
-Learn of the documents supporting this new Guidance.
-Learn about sampling, storage, handling and pooling.
-How does one transition from one bacterial endotoxin test to another -Understand the RPT (Rabbit Pyrogen Test).
-Learn about the Monocyte Activation Test (MAT).
-Determine when the Rabbit Pyrogen Test is appropriate to use in lieu of the LAL.
-Understand the issues surrounding the Low Endotoxin Recovery (LER) and its regulatory outcome
-Understand the FDA's expectation for screening of therapeutic products.

Webinar outline and time breakdown:

Date: Tuesday June 25, 2019
Time*
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Definitions,
Examine the Background of the 1987 Guidance for Industry document,
Review current testing requirements,
Overview of the NEW Guidance for Industry for LAL,
11:30 AM Break
11:40 AM Examine the Bases for the Bacterial Endotoxin Tests,
Learn of the documents supporting the proposed, new FDA Guidance,
Learn which specific Chapter is yet to be harmonized,
Learn of the typical issues confronting the end user of LAL testing,
Exploring Low Endotoxin Recovery (LER) and its regulatory outcome
Warning Letter examples,
12:30 PM Live Questions & Discussion

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

This comprehensive 9-Part live training program includes the following for each registered attendee:

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

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditors

Member Registration ►

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Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... 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

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