Blog - Page 2 of 13 - Executive Conference Corporation Webinars

PREPARING FOR A REGULATORY AUDIT (HEALTH CANADA, FDA, EMA)

Thursday September 6, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Within the past several years the regulatory agencies have advised their regulated Client firms that the enforcement environment is having the bar raised, i.e., that the regulatory agencies are no longer willing to tolerate the on-going violations that may have previously been tolerated within their Companies. As a consequence, more regulatory actions as well as the threat of seizures and consent decrees are now becoming the norm within these regulated industries. As an example, times were when it required three FDA Form 483s to create a Warning Letter. In today’s environment, this will occur after two. Import Alerts are also more frequent and usually have a Warning Letter follow within one to four months.

GMP ANNUAL TRAINING – A TWO SESSION WEBINAR – PART I

PART 1 — EXPLORING GOOD MANUFACTURING PRACTICES UPDATES AND FDA REGULATORY EXPECTATIONS

Tuesday September 18, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Annual Good Manufacturing Practices (GMP) updates are required by the FDA to assure facility personnel maintain a current understanding of regulatory requirements. These regulations utilize 21 CFR Parts 210/211 as the basis for understanding of the drug regulations; however, many other documents to include FDA’s Guidance(s) for Industry, and various other policies, to include ICH Q7, Q8, Q9, Q10, and Q11 enhance the basis for these updates and regulatory expectations.

Conducting a Successful Supplier Audit

Thursday September 20, 2018
12:00 pm – 1:30 pm EDT

Instructor: Danielle DeLucy, MS

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is a first step in selecting the correct supplier to meet your outsourcing needs.

Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

Thursday September 20, 2018
2:00 pm – 3:30 pm EDT

Instructor: Roger Cowan

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.

Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.

GMP ANNUAL TRAINING – A TWO SESSION WEBINAR – PART II

PART II — EXPLORING ADDITIONAL GOOD MANUFACTURING PRACTICES UPDATES AND FDA REGULATORY EXPECTATIONS

Tuesday September 25, 2018
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Annual Good Manufacturing Practices (GMP) updates are required by the FDA to assure facility personnel maintain a current understanding of regulatory requirements. These regulations utilize 21 CFR Parts 210/211 as the basis for understanding of the drug regulations; however, many other documents to include FDA’s Guidance(s) for Industry, and various other policies, to include ICH Q7, Q8, Q9, Q10, and Q11 enhance the basis for these updates and regulatory expectations.

THE BACTERIAL ENDOTOXINS TEST (ISSUES AND SOLUTIONS) — TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER)

Tuesday October 2, 2018
12:00 pm – 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.

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.

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

Tuesday October 9, 2018
12:00 pm – 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.

CMO Supplier Quality Agreements – How to Comply with new FDA and EU Guidelines for Contract Drug Manufacture

Wednesday October 10, 2018
1:00 pm – 2:30 pm EDT

Instructor: Roger Cowan

In 2010, the global CMO market was estimated at $26 billion dollars. Year on year growth has been 10.7% since 2008. The increasing use of outsourcing in the pharmaceutical industry along with recent well publicized quality issues with CMOs, make it a necessity to have excellent quality oversight of external manufacturers to provide assurance of GMP compliance. A Quality Agreement is one tool used to accomplish this objective.

A Quality Agreement is a contract between a pharmaceutical firm and a GMP Contract Manufacturer detailing the responsibilities of each party in assuring the quality, safety and efficacy of the manufactured drug.

Development of a Steam Autoclave Sterilization Validation Plan

Thursday October 11, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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 interactive, live 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.

CAPA/ Root Cause Analysis: Achieving Compliance with Proper CAPA Systems

Wednesday October 17, 2018
12:00 pm – 1:30 pm EST

Instructor: Danielle DeLucy, MS

Who Should Attend:

Quality Control Personnel & Management

Manufacturing Personnel & Management
Senior Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management
Supplier Quality Personnel & Management
Learning Objectives (State one to three learning objectives:

Discuss what to do when problems occur
Outline the requirements of the CAPA process and procedure including building a CAPA file
Choose the most appropriate Root Cause Analysis methods for the situation
Establishing a CAPA plan: project summary, individual responsibilities and expected completion dates
Management and Oversight of the CAPA system and its documentation

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.

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

Wednesday October 31, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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.

HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms

Thursday November 1, 2018
1:00 pm – 2:30 pm EST

Instructor: Roger Cowan

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

DEVELOPING THE KEY ELEMENTS OF A COMPREHENSIVE VALIDATION PLAN

Wednesday November 7, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Whether a Company is developing a new product or facility, the issue of developing the key elements 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 (APIs), drugs, biologics and devices and to verify equipment systems, utilities, software and processes are properly designed (DQ), installed (IQ), operate (OQ) and perform (PQ) in a consistent and controlled manner.

Risk Management of Data Integrity — To Include FDA, WHO and EMA’s Latest Guidances for Industry

Wednesday November 14, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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.

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.

Risk Management in the Development and Implementation of an Environmental Monitoring Strategy for a Controlled/Classified Environment

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

Instructor: Barry A. Friedman, Ph.D.

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.

How Creating a Culture of Quality Will Benefit Compliance

Wednesday November 28, 2018
12:00 pm – 1:30 pm EST

Instructor: Danielle DeLucy, MS

Background:
In today’s ever-increasing regulations in the Pharmaceutical world, companies have been setting stricter rules and regulations for their employees to follow to ensure they are within compliance with their regulatory authorities. It may seem like these drug makers are not concentrating on quality, meaning the quality of the process, the quality of the batch, the quality of the final product or the quality of the whole operation. As a result, we have been seeing the public relations nightmare of drug recalls, adverse events and company closures.

Regulatory Aspects of Microbiology in a Non-Sterile Environment

Thursday November 29, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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.

This 90 minute Executive Conference Corp. (ECC) webinar discusses various regulations and requirements and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Water Activity, which was out of vogue until recently, will also be reviewed. The “Art of Troubleshooting, Finding What Occurred”, will also be highlighted.

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

Tuesday December 4, 2018
1:00 pm – 2:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Sterile products may be broadly classified into two main categories based on their production mode — those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

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 December 6, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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. While some of these product applications might have been relatively easy to discern, e.g., a pre-filled syringe (usually CDER), other products may have had great difficulty finding the “correct home”.

Exploring the Breadth of Pharmaceutical Microbiological Auditing

Tuesday December 11, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Microbiology plays a role throughout the manufacture of pharmaceutical products. Whether the final product is non-sterile or sterile, bioburden still 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. In addition, any “objectionable” or “specified” microorganisms that may be encountered during the procurement of raw materials and the processing must be considered.

Implementation and Management of GMP Data Integrity

Wednesday December 12, 2018
12:00 pm – 1:30 pm EST

Instructor: Danielle DeLucy, MS

Why You should Attend The Session:
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees. Attendees will obtain an understanding of the Regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices.

Good Laboratory Practices (GLP) vs. Good Manufacturing Practices (GMPs) – A Comparison and Contrast

“Why One Should Use Only GMP Facilities for Manufacturing and Testing”

Thursday December 13, 2018
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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.

Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements

Tuesday December 18, 2018
1:00 pm – 2:30 pm EST

Instructor: Roger Cowan

Sterile filtration is one of the most critical steps in sterile pharmaceutical manufacture. This is because the filtration process provides assurance of sterility in the finished drug product.

Proper understanding and testing of the sterile filtration system according to international regulatory standards is important for both the validation and ongoing monitoring of the system.

It is important that the sterile filtration process is properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail.

THE BACTERIAL ENDOTOXINS TEST (ISSUES AND SOLUTIONS) — TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER)

Tuesday January 8, 2019
12:00 pm – 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.

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.

In addition, the FDA references 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.

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.

The Microbiology of Water in a GMP Environment

Monday January 14, 2019
12:00 pm – 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?

This live, interactive Executive Conference Corp. (ECC) training webinar presentation will also examine a variety of the issues surrounding water in a facility to include the testing of each water source and to what extent. It will cover testing requirements during commissioning and testing on an on-going basis. The webinar will examine Quality Risk Management (ICH Q9) and discuss how a properly developed Facility Water Validation Plan may lead to a logical, reduced requirement for testing vs. time.

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

Thursday January 17, 2019
1:00 pm – 2:30 pm EST

Instructor: Roger Cowan

Environmental Monitoring looks at the end results of the Environmental Control program – the microbiological and particulate quality of the clean room.

As the FDA Guideline on Aseptic Processing GMP (2004) states:

“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. This program provides meaningful information on the quality of the aseptic processing environment (e.g., when a given batch is being manufactured) as well as environmental trends of ancillary clean areas. Environmental monitoring should promptly identify potential routes of contamination, allowing for implementation of corrections before product contamination occurs.”

Therefore, ongoing environmental monitoring of a clean room environment is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

Monitoring of Bioburden – How to Manage and Control Contamination within Non-Sterile and Sterile Products

Tuesday January 22, 2019
1:30 pm – 3:00 pm EST

Instructor: Barry A. Friedman, Ph.D.

Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products is an essential element of the overall contamination control program for appropriate process control of both non-sterile and sterile products.

A typical bioburden control program includes review and analysis of potential sources of contamination commencing with each of the raw materials to include the Certificate of Acceptance of each. The microbiological contamination control program should be developed to identify and control bioburden and to assess product risk based on ICH Q9 Quality Risk Management. The bioburden risk assessment should result in the establishment of a range of critical control points which will ultimately lead to specifications for each raw material and to each unit operation as well as the drug substance (DS) and product (DP).

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.

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

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

Instructor: Barry A. Friedman, Ph.D.

USP/FDA Microbiological Non-Compliance Issues often represent 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>, <1113> and <1116>. Also, various Guidances for Industry are also cited and often used within Observations. One of the most notable Guidances is the September 2004 FDA Guidance for Industry on Aseptic Processing.

Risk Management of Raw Materials in a GMP Environment

Wednesday February 6, 2019
1:00 pm – 2:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Risk management of raw materials in a cGMP 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.

HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms

Tuesday February 12, 2019
1:00 pm – 2:00 pm EST

Instructor: Roger Cowan

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product.

Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective.

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

The Waiting Is Over – A New General Chapter, USP<60>, Burkholderia cepacia Is On The Horizon

Wednesday February 13, 2019
1:00 pm – 2:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

Burkholderia cepacia is a bacterial species that is ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this bacterium in a drug manufacturing operation is an important public health goal.

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.

Development of a Steam Autoclave Sterilization Validation Plan

Thursday February 21, 2019
1:00 pm – 2:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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 interactive, live Executive Conference Corp. (ECC) 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 of moist heat sterilization processes requiring evaluation, and describes approaches to effectively accomplish this.

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

Tuesday February 26, 2019
12:00 pm – 1:30 pm EST

Instructor: Barry A. Friedman, Ph.D.

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.

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.

Current and future trends in Lyophilization: Science based designs for optimal formulation and freeze-drying cycle development

Thursday March 7, 2019
12:00 pm – 1:30 pm EST

Instructor: J. Jeff Schwegman, Ph.D.

Over the years, scientists have strived to understand and apply scientific principles to the formulation and process development of freeze-dried products. As opposed to using a “trial and error” approach, modern formulation and process development scientists have the information and tools necessary to design an optimal formulation and lyophilization cycle using a scientifically based empirical approach. By understanding the scientific principles and physical properties of the formulation and the lyophilization process, the development scientist can design a product that is produced in the most cost effective manner, in the least amount of time, is of the highest quality, and has adequate long term stability. Additionally, there have been many new and exciting technologies on the horizon, or in the early stages of implementation, in freeze-drying equipment. Several of these new technologies will be discussed in regards to both production-scale and development-scale freeze-dryers, and details on the advantages and or disadvantages of each will be discussed.

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

Tuesday March 12, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Sterile products may be broadly classified into two main categories based on their production mode — those that are terminally sterilized following the filling and sealing of the container and those that are aseptically sterilized, that is, filter sterilized as a bulk product, filled and then sealed. Aseptic processes play a critical role with large molecules that cannot be terminally sterilized. The verification of the process to produce sterile product is evaluated by the demonstration of various media fill process simulations that will vary in both numbers and size of the containers as well as the volumes filled over a defined period of time.

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

Wednesday March 13, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

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.

The question often arises as why my Company is experiencing these deviations? Very often the answer is simple laboratory errors that require minimal training to correct. In other situations personnel are experiencing difficulties with understanding the USP or the standard operating instructions (SOPs) from which these SOPs are derived. In still other situations, these problems are being caused by management, and personnel require their assistance to minimize these complex periodic issues.

Pharmaceutical Compressed Air – Quality GMP Standards and Requirements

Thursday March 14, 2019
1:00 pm – 2:00 pm EDT

Instructor: Roger Cowan

Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product.

The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product.

Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system.

Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system.

PREPARING FOR A REGULATORY AUDIT (HEALTH CANADA, FDA, EMA)

Tuesday March 26, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Within the past several years regulatory agencies have advised their regulated Client firms that the enforcement environment is having the bar raised, i.e., that the regulatory agencies are no longer willing to tolerate the on-going violations that may have previously been tolerated within their Companies. As a consequence, more regulatory actions as well as the threat of seizures and consent decrees are now becoming the norm within these regulated industries. As an example, historically it required three FDA Form 483s to create a Warning Letter. In today’s environment, this will occur after two. Import Alerts (for overseas audits) are also more frequent and usually have a Warning Letter follow within one to four months.

This interactive, Executive Conference Corp. (ECC) webinar is appropriate for those producing small molecules, large molecules and dietary supplements. It will review the strategies that an organization should follow in preparing for an inspection. It will include everything from how the facilities should be maintained in anticipation of an audit to assuring that the Quality Control laboratories do not incriminate the overall facilities. Also, this webinar will include a discussion of employee training and what Annual Training should mean within your organization — and what it does not mean. Areas such as deviations, Out of Specification (OOS), and Corrective Actions/Preventive Actions (CAPAs) will be discussed and include how regulatory agencies initially request these upon their arrival and why. The issue of qualification and validation and the impact of the relatively new FDA Process Validation guidance will also be reviewed.

Risk Management of Data Integrity To Include FDA, WHO and EMA’s Latest Guidances for Industry

Thursday March 28, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

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.

Often the initial “hint” of an off-shore problem occurs within FDA “circles” when one first observes an “Import Alert”. These Import Alerts don’t offer much information other than the country, the Company and the product. However, this becomes a tell-tale signal that a Warning Letter will most likely be issuing within three to four months.

Understanding and Troubleshooting Pharmaceutical Water Systems

Thursday April 4, 2019
12:00 pm – 1:30 pm EDT

Instructor: Nissan Cohen

“Understanding and Troubleshooting Pharmaceutical Water Systems” is a comprehensive presentation on the depiction and assessment of different water purification modules used in pharmaceutical water systems. This presentation explains the design requirements, usage, and reasoning for the institution of a given process module in the pharmaceutical water system producing Purified or WFI waters.

There are many permutations and selection alternatives for pharmaceutical process modules to attain regulatory compliance to USP or regulatory mandated water quality. This presentation outlines alternatives and options allowing for increased flexibility in choosing the correct modules to produce Purified Water (PW) or Water for Injection (WFI) final product waters.

The Waiting Is Over – A New General Chapter, USP<60>, Burkholderia cepacia Is On The Horizon

Tuesday April 9, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that are contaminated with B. cepacia and/or its Complex may pose serious issues to infants, elderly and immunocompromised individuals. Preventing B. cepacia contamination in drugs by addressing the potential sources of this bacterium in a drug manufacturing operation is an important public health goal.

Historically, when the USP was revised in May 2009, it was modified to include both USP<61> and USP<62>, and harmonized with both the European Union (EU) and Japanese Pharmacopeia (JP). B. cepacia was excluded at that time as a “specified” bacterium – even though many individuals believed that it should have been included. In addition, it was not included within USP<1111> when it also was modified several years ago. One of the main reasons that all believed that it should have been included was because of the frequency in which it occurs and the diversity of environments and products in which it has been found.

DEVELOPING THE KEY ELEMENTS OF A PROCESS VALIDATION PLAN

Wednesday April 10, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Whether a Company is developing a new product or facility, the issue of developing the key elements 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 (APIs), drugs, biologics and devices and to verify equipment systems, utilities, software and processes are properly designed (DQ), installed (IQ), operate (OQ) and perform (PQ) in a consistent and controlled manner.

The purpose of validation is to assure the facility, manufacturing process, and supporting services are capable of supporting the manufacture of pharmaceutical and device products that consistently meet their predetermined quality attributes. The Validation Master Plan (VMP) uses a “life cycle” approach and emphasizes Quality Risk Management (ICH Q9) as the Plan proceeds from validation through verification and qualification. The VMP is intended to project a picture of how your company has integrated current Good Manufacturing Processes (cGMP) as promulgated in 21 CFR Part 820 and 211, into all aspects of the manufacturing process. The Validation Program is designed to proactively assure GMP compliance from facility development through the distribution of final product.

Regulatory Aspects of Microbiology in a Non-Sterile Environment

Tuesday April 16, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

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.

This 90 minute Executive Conference Corp. (ECC) webinar discusses various regulations and requirements and how they impact non-sterile manufacturing to include the setting of specification, development of the process, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Water Activity, which was out of vogue until recently, will also be reviewed. The “Art of Troubleshooting, Finding What Occurred”, will also be highlighted.

Products that are sold as sterile, but include a non-sterile phase within their manufacturing cycle will be reviewed since the Regulators often have concerns regarding these in-process materials. Thoughts about in-house microorganisms that may be considered as “specified” vs. “objectionable” to include the B. cepacia Complex will also be discussed. Warning Letters, Recalls and USP Chapters will be used to highlight the various discussion points.

Uncertainty in (FDA and USP) Laboratory Measurements within the Microbiological & Chemistry Arena that are Related to FDA Compliance and Recent Warning Letter Review

Thursday April 18, 2019
12:00 pm – 1:30 pm EDT

Instructor: Barry A. Friedman, Ph.D.

Measurements within the R&D and Quality Control Laboratories often create issues with those involved — whether it be the technician, supervisor or laboratory manager. These measurement issues may be extremely simple or very difficult to discern based on the newness of the assay, its complexity, the training of the personnel, etc. The FDA will often comment on a Client’s difficulty to follow/interpret an assay — whether it be a USP/EP/JP assay or one developed by the Client.

The assays may vary based on the compendial method being followed, e.g., USP, EP, or JP or, because no method exists. Often the development of new technologies also require the development of new assays or comparable assays that achieve levels of precision, accuracy and quantitation (see USP 1223, 1225) that have not been previously achieved.
Warning Letters will be presented to document some of the various testing issues that the FDA has discovered during recent audits and include recommendations where possible.