Best Practices for Deviation Investigations
Tuesday April 30, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Course Description:
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan. Learn how to identify and classify deviations for easier management and investigation.
Annual Laboratory Microbiology Training
Wednesday May 1, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
The Laboratory Environment, and, in particular, the Microbiology laboratory, have definite Annual GMP Training requirements that necessitate “refreshing” (see 21 CFR 210/211, Section 25). With a constant influx of new and revised FDA Guidances for Industry, USP General and General Information Chapters, ISO, Canadian and EU requirements, Standard Operating Procedures (SOPs) are always in flux. In addition, with a continuum of Form FDA 483 Observations and Warning Letters providing “new twists” to what is expected of the Microbiology Laboratory Environment, the studying of these FDA compliance documents from a microbiological perspective can be most helpful.
A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom
Thursday May 2, 2024
12:00 Noon – 1:30 pm (NY Time)
Instructor: Jim Polarine
Abstract:
This seminar will cover a risk-based approach to an Aspergillus brasiliensis contamination in a Cell and Gene Therapy Cleanroom. Details will be provided on how to follow a risk-based approach utilizing a fishbone diagram and the five whys centered on using good science. The most common causes of contamination will be conveyed in case studies with fungal spore contamination. New efficacy testing data will be covered on Chaetomium and Aspergillus. A recent case study will be covered in detail as well as microbial identifications and how to utilize a risk-based approach. Solutions are going to be conveyed on how to proactively prevent fungal contamination from reoccurring.
Effective Regulatory Inspections
Tuesday May 7, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
Development of a Steam Autoclave Sterilization Validation Plan
Wednesday May 8, 2024
12:00 pm – 1:30 pm (NY Time)
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. This guideline, derived from Health Canada guidances, specifies the minimum documentation required to certify that moist heat sterilization processes have been thoroughly evaluated and are adequately controlled and validated.
MICROBIOLOGY FOR THE NON-MICROBIOLOGIST – AND THE MICROBIOLOGIST WHO DESIRES A GMP MICROBIOLOGICAL REFRESHER
Thursday May 9, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
With the increasing number of Regulatory Actions throughout North America to include Form FDA 483s and Warning Letters for both Active Pharmaceutical Ingredients (APIs) and finished product, it has become increasingly important for Companies and individuals manufacturing both non-sterile and sterile final products, to have a basic understanding of microbiology — regardless of the Department in which they work. Every individual within varying Departments from Facilities to Manufacturing to Quality Control should understand the basics of microbiology and the issues that non-compliance can create. Recently, a large multi-national pharmaceutical company was cited for the second time by the FDA for not determining that mold was growing on the “clean side” of the HEPA filters in an ISO Class 5 environment after it had been identified by mechanics several years previously.
How to Detect Lack of Data Integrity
Tuesday May 14, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Ronald D. Snee, PhD
Data are central to the development, manufacture and marketing of pharmaceuticals of all types. The renewed interest in data integrity raises questions regarding what is data integrity and how to assess it. Lack of data integrity comes in two forms: purposeful manipulation of the data to deceive and the inadvertent problems that occur in the production and analysis of data. Humans, equipment or both can be the source of the problem.
Pharmaceutical Compressed Air – Quality GMP Standards and Requirements
Thursday May 16, 2024
1:00 pm – 2:30 pm (NY Time)
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.
VALIDATION MASTER PLANNING (DEVELOPING A COMPREHENSIVE VALIDATION PACKAGE)
Wednesday May 22, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
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 (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.
Effective Batch Record Review
Thursday May 23, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
Risk Management of Raw Materials in a GMP Environment
Tuesday June 11, 2024
12:00 pm – 1:30 pm (NY Time)
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.
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 June 13, 2024
12:00 pm – 1:30 pm (NY Time)
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.
Bioburden Control of Non-Sterile Drug Substances and Products– A New USP General Information Chapter
Wednesday June 19, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
USP recently released a “General Information Chapter” 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 non-sterile manufacturers have repeatedly asked the question “what degree of microbial cleanliness should I require with my non-sterile 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 answer 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”.