active Archives - Executive Conference Corporation Webinars

Is Your Environmental Monitoring Program Risk-Based?

Tuesday, January 9, 2018
11:30 – 1:00 pm EST

Instructor: Marsha Steed (Hardiman)

Non-viable air and viable air and surface monitoring of controlled environments is not a new concept and has been a regulatory requirement for many years. In the past, many companies selected Environmental Monitoring (EM) sample locations based on a grid approach of dividing up the rooms and taking samples inside all of the grids. Current regulatory requirements involve taking risk based approaches in the manufacturing of products, including Environmental Monitoring. Does your current EM Program consist of many floor and wall sample locations? Do you ever ask yourself if the data you are collecting every week/month/year in your EM Program is value added?

QUALITY METRICS AND THE ISSUES WITH THE FDAs DRAFT GUIDANCE QUALITY METRICS

Thursday, January 11, 2018
NOON – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

The FDA Safety and Innovation Act (FDASIA) of 2012 provides a firm the legal basis for setting clear standards and for collecting data to assess manufacturing operations. Section 705 of FDASIA requires FDA to establish a risk based schedule for inspecting drug manufacturing sites, and requires access to more detailed information on facilities and quality controls. Section 706 authorizes the Agency to obtain information on drug production sites and operations in advance of an inspection. Together, these two Sections support FDA’s strategy for improving how it assesses the ability of a manufacturing site to consistently produce medicines fit for intended use. This following DRAFT Guidance represents a follow-up to FDASIA.

Risk Management of Raw Materials in a GMP Environment

Thursday, January 18, 2018
NOON – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Risk management of raw materials in a GMP environment is an area that is often overlooked as a Company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live, interactive presentation will extensively review this area. It will also delve into the renewed issue of microbial and endotoxin contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on them.

Aseptic Processing Necessities

Tuesday, January 23, 2018
11:30 – 1:00 pm EST

Instructor: Marsha Steed (Hardiman)

Manufacturing of pharmaceutical, biopharmaceutical or medical device products via aseptic processing requires knowledge and understanding of the basic principles of Microbiology in order to manage the aseptic operations and produce sterile products. Lack of understanding about good aseptic technique, proper facility design, adequate cleaning and correct cleanroom behaviors can lead to contamination of product, time consuming investigations and rejection of production batches. In this course we will discuss:

UNDERSTANDING THE BACTERIAL ENDOTOXIN TEST TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER)

Thursday, January 25, 2018
NOON – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

On Tuesday, July 12, 2011, the FDA posted on their web site 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.

The Microbiology of Water in a GMP Environment

Tuesday, January 30, 2018
NOON – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

Tuesday, February 6, 2018
12:00 Noon – 1:30 pm EST

Instructor: Jim Polarine

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

Robust and Risk-Based Media Fill Programs

Thursday, February 8, 2018
12:00 Noon – 1:30 pm EST

Instructor: Marsha Steed (Hardiman)

The Aseptic Process Simulation (APS), which is commonly referred to as the Media Fill, is a critical piece in the aseptic manufacturing of sterile pharmaceutical and medical device products. Verification of the aseptic manufacturing process to produce sterile products is performed by simulating the manufacturing process with media.

USP/FDA Microbiological Non-Compliance Issues in a Bipharmaceutical/Pharmaceutical Environment

Thursday, February 15, 2018
12:00 Noon – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

USP/FDA Microbiological Non-Compliance Issues represent often observed problems that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. Various regulators will cite firms for these non-compliance issues under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192. Non-compliance issues are also cited as per United States Pharmacopeia to include USP<51>, <61>, <62>, <71>, <1072>, <1111>, and <1116>. Also, various Guidances for Industry are also included and often used within citations. One of the most notable is the September 2004 FDA Guidance for Industry on Aseptic Processing.

Sterility Test Failure Investigations

Tuesday February 20, 2018
12:00 Noon – 1:30 pm EST

Instructor: Marsha Steed (Hardiman)

The sterility test is a critical lot release component for the manufacturing of sterile products. When sterility test positives are observed, a thorough and formal investigation is required. The compendial sterility test methodologies are harmonized for the United States, Europe and Japan.

Creating Your Monitoring Plan and Risk Assessment for ISO 14644-1,2

Thursday, February 22, 2018
12:00 Noon – 1:30 pm EST

Instructor: Marsha Steed (Hardiman)
The ISO Standards for cleanrooms and associated controlled environments, ISO 14644-1 Classification of air cleanliness by particle concentration and ISO 14644-2 Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration have been updated and have been effective since 12Dec2015.

FDA Contract Manufacturing Arrangements for Drugs: Quality Agreements – Their Relationship to Microbiological Issues

Tuesday, February 27, 2018
12:00 Noon – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Written Quality Agreements are not explicitly required under existing CGMP regulations and do not relieve either party of their responsibilities under CGMP regulations or under the FD&C Act 501(a)(2)(B). However, Owners and Contracted Facilities can draw on quality management principles to initiate the complicated process of contract drug manufacturing by defining, establishing, and documenting the responsibilities of all parties involved in drug manufacturing, testing, or other support operations. Accordingly, FDA recommends that Owners and Contracted Facilities implement written Quality Agreements as a tool to delineate responsibilities and assure the quality, safety, and effectiveness of drug products.

FDA’s Combination Products and Its Impact on Manufacturers of Pharmaceuticals, Biopharmaceuticals, Medical Devices and HCT/P – The Final Guidance, “Current Good Manufacturing Practice Requirements for Combination Products”

Thursday March 8, 2018
1:30 pm – 3 pm EST

Instructor: Barry A. Friedman, Ph.D., LLC

Historically, the absence of clear cGMP requirements for Combination Products has resulted in inconsistent application as to the applicable Agency Center to submit product for review. Products for both CDER and CDRH as the primary Agency contact point may have historically been submitted to the incorrect organization for review because of a lack of knowledge as to the Primary Mode of Action (PMOA) of the product.

Exploring the Breadth of Pharmaceutical Microbiological Auditing

Thursday March 15, 2018
1:30 pm – 3 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC

Microbiology plays a role throughout the manufacture of pharmaceutical products. 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.

Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs)

Thursday March 22, 2018
1:30 pm – 3 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC

A Comparison and Contrast – “Why One Should Use Only GMP Facilities for Manufacturing and Testing”.
Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 Good Laboratory Practices (GLP) and therefore they meet all of the cGMP requirements”.

KEY ELEMENTS OF A COMPREHENSIVE VALIDATION PLAN

Tuesday March 27, 2018
10:00 am – 11:30 am EDT

Instructor: Barry A. Friedman, Ph.D., LLC

Whether a Company is developing a new product or facility, the issue of a comprehensive Validation Package is essential to assure the timely completion of all activities. A Validation Package is designed to satisfy both current domestic and international regulations, guidelines and policies for active pharmaceutical ingredients

Standard Industry Practices in Bio/Pharma/Micro Industries

Thursday April 5, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)

Biotechnology/Pharmaceutical/Microbiological Urban Myths have created a very interesting landscape for many years. As personnel turnover continues to occur within the pharmaceutical/biotechnology arena, these Urban Myths again are thriving. Often the term that one hears is “standard industry practices” – but what does it mean? Does this infer that the “practices” are sanctioned by the government or industry?

Cleaning and Cleaning Validation

Tuesday April 10, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

Disinfection and Cleanroom Cleaning

Thursday April 12, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

Applying Risk to Cleanroom Qualification

Tuesday April 17, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Marsha Steed (Hardiman)

Qualification of a cleanroom is a critically important task for any healthcare company manufacturing in controlled environments. There is often a push from management to get the new cleanroom(s) or renovated cleanroom(s) into a state that is ready for production use as soon as possible. The proper balance of compliance and business risk often comes into play.

Development of a Steam Autoclave Sterilization Validation Plan

Wednesday April 18, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)

Terminal moist heat sterilization is presently considered the method of choice to ensure sterility. All aqueous-based sterile products are subject to terminal moist heat sterilization unless the sterilization, itself, will degrade the product. This webinar is intended to provide manufacturers of pharmaceutical dosage forms as well as components (vials and stoppers) with guidance to establish the scientific effectiveness of moist heat sterilization processes. It has been developed as an overview of the elements in moist heat sterilization processes requiring evaluation and describes approaches to effectively accomplish this.

Microbial Data Deviation Investigations — Latest FDA & ICH Requirements and Guidance

Tuesday April 24, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)

Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to attempting to determine the “root cause” of a sterility test failure. The resultant investigations and their data requirements may be very short in duration, e.g., a matter of only several to 40 – 50 hours. However, unlike chemical analytical deviations and their Out Of Specification (OOS) studies and Corrective/Preventive Action (CAPA) programs, the length of time to complete these microbiological investigation studies may extend to as many as six months based on the biological laboratory studies that may be required.

Exploring Data Integrity to Include FDA, WHO and EMA’s Latest Guidances for Industry

Wednesday April 25, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore with a greater frequency than usually observed within the United States. A lack of Data Integrity hints of a Company being outside of compliance and questions the quality of the product being produced.

Managing Microbiological Deviations

Wednesday May 2, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Managing Microbiological Deviations (Non-Conformances), Out of Specification (OOS), Out of Trend (OOT) and Corrective Actions/Preventive Actions (CAPA) in Sterile and Non-Sterile Production

Microbiological Deviations (Non-Conformances), Out of Specifications (OOS), Out of Trend (OOT), and Corrective Actions/Preventive Actions (CAPA) may occur with the production of both non-sterile and sterile products.

Validation of Microbiological Test Methods

Thursday May 3, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Validation of Microbiological Test Methods represents a basic requirement within the pharmaceutical/biotech industries to assure that microbiological methods are reproducible and consistent, that methods developed for one product type will perform or be modified to perform for another product type, to improve process reliability and demonstrate product safety and reliability. Validations are also developed to determine both Alert and Action Levels as well as acceptable limits and specifications for microbiological test methods. Finally, regulatory pressures also expect that methodologies are validated as required and not merely qualified or verified.

Cleaning Validation – Visible Residue Limit Determination and Ruggedness

Tuesday May 8, 2018
12:00 pm – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the use of Visible Residue Limits (VRLs) for cleaning validation for product contact surfaces of equipment in the pharmaceutical industry. VRLs are the level below which no residue is visible under defined parameters and are applicable for cleaning validation when they are lower than the calculated cleaning acceptance limit.

VRLs can be established for APIs, products, excipients, and detergents as needed. Decreasing amounts of material are spiked onto coupons and dried. The dried coupons are viewed under defined viewing conditions by a number of observers, who determine the lowest level of material they can see. The VRL is the lowest level of material that all observers can see under the defined viewing conditions.

Developing and Implementing an Environmental Monitoring Strategy for a Controlled/Classified Environment

Wednesday May 16, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D., LLC (more about the Instructor)

Environmental monitoring of controlled and classified environments and their systems is required to maintain compliance with EMA/FDA/Health Canada requirements. To perform this task, knowledge of the fundamentals of the systems and their requirements is a must. Doing this requires the ability to identify the “key” elements of the Monitoring Program. Understanding the regulations and the regulatory expectations must be accomplished to assure that all of the necessary SOPs, appropriate specifications and testing are developed, implemented and met. Relying on obtaining from others that a procedure must be executed in a specific way to “meet industry standards” or “meet industry expectations” leads only to disastrous consequences. Learning what documents form the foundation is required for the knowledge base.

Disinfection and Cleanroom Cleaning

Thursday May 17, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

Cleaning Validation of APIs

Tuesday May 22, 2018
12:00 pm – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of cleaning validation for Active Pharmaceutical Ingredients (APIs) from product contact surfaces of equipment in the pharmaceutical industry. All phases of cleaning validation: cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed with the emphasis on the unique challenges and opportunities for an API cleaning validation program.

The cleaning assessment phase evaluates the types of residues associated with API manufacturing, their interrelationships the challenges they present for cleaning. The cleaning process is evaluated in relation to the next batch or product to be manufactured and the level of cleanliness required for the next batch or product is addressed.

Risk Management of Raw Materials in a GMP Environment

Thursday May 31, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Risk management of raw materials in a GMP environment is an area that is often overlooked as a Company develops new products. Depending on the product being developed, e.g., tablets and capsules vs. biotechnology products, as few as fifteen to twenty raw materials or as many as sixty need to be sourced and accepted before the process can be moved from initiation through completion. This live, interactive presentation will extensively review this area. It will also delve into the renewed issue of microbial and endotoxin contamination of these raw materials and why the FDA, EMA and Health Canada have recently focused on them.

Regulatory Aspects of Microbiology in a Non-Sterile Environment

Tuesday June 5, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules have historically been minimal when compared to aseptic manufacturing. These rules have included the handling and evaluation of non-sterile components, the environment and final product, but not to the extent of sterile products.

UNDERSTANDING THE BACTERIAL ENDOTOXIN TEST TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER)

Tuesday June 12, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

On Tuesday, July 12, 2011, the FDA posted on their web site 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.

Disinfection and Cleanroom Cleaning

Wednesday June 13, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

Aseptic and Parametric Sterilization Methods as Modes for Rapid Release of Sterilized Products

Tuesday June 19, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Within the medical industry a number of sterilization methods are available to assure that products are produced that are devoid of any microorganisms. All of these methods render a product sterile; however, some of these methods provide a Sterility Assurance Level (SAL) or Probability of Non-Sterility (PNS) that are greater than others, i.e., provide a greater confidence level that no viable microorganisms remain viable within the final sterile product.

Terminally sterilized products represent the lowest risk category of sterile pharmaceutical and medical device products. Unlike products aseptically manufactured in a microbiologically controlled environment, terminally sterilized products are subjected to a sterilization process that imparts a measurable minimum SAL.

Quality Metrics and the “Issues” with the FDA’s Draft Guidance “Quality Metrics” (November 2016)

Tuesday June 26, 2018
1:30 pm – 3:00 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

The FDA Safety and Innovation Act (FDASIA) of 2012 provides a firm the legal basis for setting clear standards and for collecting data to assess manufacturing operations. Section 705 of FDASIA requires FDA to establish a risk based schedule for inspecting drug manufacturing sites, and requires access to more detailed information on facilities and quality controls. Section 706 authorizes the Agency to obtain information on drug production sites and operations in advance of an inspection. Together, these two Sections support FDA’s strategy for improving how it assesses the ability of a manufacturing site to consistently produce medicines fit for intended use. This following DRAFT Guidance represents a follow-up to FDASIA.

Analytical Method Validation for Cleaning Validation Residues

Thursday June 28, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of analytical method validation for cleaning validation swab samples for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All phases of method validation: validation parameters, regulatory expectations, designing the method, designing the method validation protocol, instrumentation, method validation execution and method transfer will be discussed with the emphasis on the unique challenges and opportunities for a cleaning validation program.

Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs)

A Comparison and Contrast – Why One Should Only Use GMP Facilities for Manufacturing and Testing

Tuesday July 17, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Periodically one hears the comment that “a laboratory or a manufacturing facility meets 21 CFR Part 58 Good Laboratory Practices (GLP) and therefore they meet all of the cGMP requirements”. Contrary to popular belief, 21 CFR Part 58 is not the equivalent of 21 CFR 210/211 and does not meet the same requirements as 210/211. They (Part 58) do have the force of law and are not “watered down” GMPs.

Good Manufacturing Practices (cGMPs) represents that part of Quality Assurance that ensures that products are consistently produced and controlled to the Quality standard appropriate to their intended use and as required by the product specification. They fall within the requirements of 21 CFR Parts 210/211 and support final product requirements for humans and animals.

The Microbiology of Water in a GMP Environment

Wednesday July 18, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D. (more about the instructor)

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even companies manufacturing tablets need to be aware of the quality of the water that may be contacting their process or product. The well-being of a facility revolves around the health of each water system within that facility. How often have we learned of a facility being closed for weeks at a time because of a water system that has exceeded its microbiological specifications?

Disinfectant Validation: Debates and Challenges

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Thursday July 19, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.

Cleaning and Cleaning Validation

Thursday July 26, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

Disinfection and Cleanroom Cleaning

Tuesday September 4, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

Disinfectant Validation: Debates and Challenges

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Monday October 22, 2018
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.

Disinfection and Cleanroom Cleaning

Tuesday November 20, 2018
12:00 Noon – 1:30 pm EST

Instructor: Jim Polarine

Understanding Disinfection and Cleanroom Cleaning in a FDA Regulated Environment

This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues.

A Risk Based Approach to Cleaning and Disinfection

Wednesday January 9, 2019
12:00 Noon – 1:30 pm EST

Instructor: Jim Polarine

This seminar will cover the current industry regulations in the US, Europe and Globally related to cleaning and disinfection. Regulatory expectations will be covered including the latest revision of Annex I and recent FDA Warning Letters and 483’s related to cleaning and disinfection will be covered. The current antimicrobial products used in cleanroom industry will be discussed. Cleaning frequency, disinfectant rotation, rinsing and residue removal, disinfectant coverage calculations, and the most current equipment and methodologies for cleaning and discinfection will be covered in detail. The topic of sterility as it relates to cleanroom disinfectants and sporicides will be explained. This seminar will provide the audience with the ability to design and effective risk-based approach to cleaning and disinfection.

Cleaning and Cleaning Validation

Tuesday January 29, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Tuesday February 19, 2019
12:00 Noon – 1:30 pm EST

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.

Analytical Method Validation for Cleaning Validation Residues

Thursday February 28, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a detailed overview of analytical method validation for cleaning validation swab samples for Active Pharmaceutical Ingredients (APIs) and detergents from product contact surfaces of equipment in the pharmaceutical industry. All phases of method validation: validation parameters, regulatory expectations, designing the method, designing the method validation protocol, instrumentation, method validation execution and method transfer will be discussed with the emphasis on the unique challenges and opportunities for a cleaning validation program.

Risk Based Approach to Cleaning & Disinfection

Tuesday April 23, 2019
12:00 Noon – 1:30 pm EDT

Instructor: Jim Polarine

This seminar will cover the current industry regulations in the US, Europe and Globally related to cleaning and disinfection. Regulatory expectations will be covered including the latest revision of Annex I and recent FDA Warning Letters and 483’s related to cleaning and disinfection will be covered. The current antimicrobial products used in cleanroom industry will be discussed. Cleaning frequency, disinfectant rotation, rinsing and residue removal, disinfectant coverage calculations, and the most current equipment and methodologies for cleaning and discinfection will be covered in detail. The topic of sterility as it relates to cleanroom disinfectants and sporicides will be explained. This seminar will provide the audience with the ability to design and effective risk-based approach to cleaning and disinfection.

Cleaning and Cleaning Validation

Tuesday May 14, 2019
12:00 Noon – 1:30 pm EST

Instructor: Richard Forsyth

This Web Seminar will present a comprehensive overview of the life-cycle approach to cleaning for product contact surfaces of equipment in the pharmaceutical industry. The four phases of cleaning : cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed including how they contribute to a compliant, evolving cleaning program.

The cleaning assessment phase evaluates either the current cleaning procedure or a proposed change to the current cleaning procedure against the current regulatory cleaning validation expectations. Any necessary remediation strategy for the assessment is determined in order to define an efficient cleaning development study.

Debates and Challenges Concerning Disinfectant Validation and Methods to Circumvent Them

Wednesday June 12, 2019
12:00 Noon – 1:30 pm EST

Instructor: Jim Polarine

This presentation covers current debates in the industry regarding disinfectant coupon testing. PDA Technical Report No. 70 and USP 39 <1072> will be covered in relation to current industry disinfectant efficacy testing. Recent FDA Warning Letters and 483s will be covered that highlight regulator expectations in disinfectant efficacy testing. Data will be presented covering the importance of disinfectant efficacy testing with specific bacterial spores which can be more difficult to kill than ATCC strains. Both sides of the debate on disinfectant validation will be covered in detail with an emphasis on current FDA, MHRA, ANVISA, and HPRA regulatory expectations and reducing the costs for testing.

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