A Roadmap to a Successful Contamination Control Strategy (CCS): Covering Annex I Updates and FDA Warning Letters and 483’s
Wednesday March 20, 2024
12:00 Noon – 1:00 pm (NY Time)
Instructor: Jim Polarine
This seminar will cover the recent updates from the newly released Annex I related to cleaning and disinfection, validation of disinfectants in cleanrooms including RABS and isolators. Additionally, recent FDA Warning Letters and 483’s related to cleaning and disinfection and validation of disinfectants best practices will be discussed. Case studies involving ineffective contamination control programs will be highlighted including ways to improve these overall programs. The attendees will receive a robust roadmap describing ways they can improve their contamination control strategy and avoid regulatory citations.
Sterile Filtration of Pharmaceutical Products – Validation and Regulatory Requirements
Thursday March 21, 2024
1:00 pm – 2:30 pm (NY Time)
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.
CAPA/Root Cause Analysis: Achieving Compliance with Proper CAPA Systems
Monday,April 1 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Course Description:
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects and ensure they stay on track.
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile ProductionFDA & ICH Expectations and Guidance
Tuesday March 26, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
Microbiological Out of Specifications (OOS) may occur with the production of both non-sterile and sterile products. They may occur as early in the process as with Incoming Raw Materials and extend throughout In-process and Active Pharmaceutical Ingredient (API) phases to the final product.
With the advent of the revised USP<61> Microbial Examination of Nonsterile Products: Microbial Enumeration Test, a new latitude in result interpretation has come to the fore; however, one needs to understand how to utilize this inherent variation of USP<61> with Out of Trend (OOT) and Out Of Specification (OOS).
Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs
Wednesday March 27, 2024
12:00 pm – 1:30 pm (NY Time)
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.
Proper Root Cause Analysis
Thursday March 28, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Why You should Attend The Session
If you have reoccurring problems showing up in your quality systems, your Quality system is not effective and you have not performed an in-depth root cause analysis to be able to detect through proper problem solving tools and quality data sources, the true root cause of your problem. Unless you can get to the true root cause of a failure, nonconformity, defect or other undesirable situation, your Quality System will not be successful. Historically, 483s in the pharmaceutical industry related to CAPAs, are due to lack of inadequate root cause investigations, among other factors.
HVAC and GMP Environmental Control – for Pharmaceutical Clean Rooms
Tuesday April 16, 2024
1:00 pm – 2:30 pm (NY Time)
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.
FDA Contract Manufacturing Arrangements for Drugs: Quality Agreements — Their Relationship to Microbiological Issues
Wednesday April 17, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
Has your Company ever been in a situation where you find that a process requires Qualification, or an assay requires Validation and you and your Client do not have a clear understanding as to whom who should be paying for it? And, as a result, you and your Client come to a stalemate and nothing is done? And, to make matters worse, the FDA shortly arrives thereafter and cites both you and your Client for this non-compliance? Through your participation in this webinar, you should arrive at an understanding of how to manage these situations and avoid the citations from which these situations arise by gaining an enhanced understanding of “Written Quality Agreements”.
Quality System Management Effectiveness
Thursday April 18, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Background:
In many Life Sciences companies, “quality” becomes a “buzz” word. In an industry which is one of the most regulated in the world, quality should come first when a company wants to be productive. If designed properly, quality management systems can help a company achieve its compliance goals and its business goals. With regulations from FDA, EU and others becoming more and more stringent, Companies must optimize resources to effectively achieve their quality goals and find their optimal balance between cost and risk.
THE BACTERIAL ENDOTOXINS TEST (ISSUES AND SOLUTIONS) TO INCLUDE THE ISSUE OF LOW ENDOTOXIN RECOVERY (LER) AND TR 82 (PDA) AND GENERAL INFORMATION CHAPTER <1085>
Tuesday April 23, 2024
12:00 pm – 1:30 pm (NY Time)
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.
TERMINALLY STERILIZED PHARMACEUTICAL PRODUCTS—PARAMETRIC RELEASE (NEW USP<1222>, November 2019) AND ITS RELATIONSHIP TO THE NEW BRITISH TERMINAL STERILIZATION METHODOLOGY (March 2019)
Wednesday April 24, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Barry A. Friedman, Ph.D
Parametric release is defined as the release of terminally sterilized batches or lots of sterile products based upon compliance with the defined critical parameters of sterilization without having to perform the testing requirements under USP<71> Sterility Tests.
Parametric release becomes possible when the mode of sterilization is 1) very well understood, 2) the physical parameters of processing are well defined, predictable, and measurable, 3) and the lethality of the cycle has been microbiologically validated through the use of appropriate biological indicators or, in the case of ionizing radiation, the appropriate microbiological and dosimetric tests.
SOLVING STATISTICAL MYSTERIES – WHAT DOES THE FDA WANT?
Thursday April 25, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Ronald D. Snee, PhD
Use of statistics has been part of the FDA’s guidances and regulations for many years. Use of statistics is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.
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.
Effective Regulatory Inspections
Tuesday May 7, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Background:
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.