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Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms
Henry Urbach
60 Min
Product Id: 702635
This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.
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FDA Inspection Preparedness
Susan Muhr Leister
60 Min
Product Id: 704221
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
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FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
Angela Dunston
90 Min
Product Id: 704431
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
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Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance
Gaurav Walia
75 Min
Product Id: 704370
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
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Process Robustness: The New FDA Paradigm
Angela Dunston
90 Min
Product Id: 703990
In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.
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Making Sense of BSCs, Hoods, Isolators, RABs
Joseph Winslow
60 Min
Product Id: 704361
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
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Validation of Purified Water Systems
Igor Gorsky
150 Min
Product Id: 704272
This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).
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Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach
Jerry Dalfors
80 Min
Product Id: 703633
This course will detail various sterilization methods and various approaches for the validation of a sterilization process.
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The Microbial Factor of Non-Sterile Cleaning Validation
Steve Yeger
60 Min
Product Id: 703360
This webinar will focus on the microbiological element of non-sterile manufacturing cleaning validation and the need to design a robust cleaning routine. It will address the different pharmacopoeia regulations and current regulatory trends. It will also cover the theory in setting the baseline profile and limits along with determination of routine testing.
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Lyophilization Technology
Jerry Dalfors
80 Min
Product Id: 704028
This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.
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FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)
Mukesh Kumar
90 Min
Product Id: 703652
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
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How to Most Effectively Prepare for and Manage FDA Inspection: Best Practices
David Lim
60 Min
Product Id: 703245
This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.
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Good Documentation Practices (GDP)
Alla Teresh
60 Min
Product Id: 703874
This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
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Preparing for and Managing FDA Inspections
Jonathan M Lewis
90 Min
Product Id: 703512
This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.
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Best Practices for Cleaning and Material Handling in Sterile Compounding Facilities
Kate Douglass
60 Min
Product Id: 703807
This webinar will clarify the cleaning and material handling requirements outlined in USP 797 and present additional best practice guidelines. It will discuss principles related to the selection, preparation and use of cleaning, disinfection and deactivation agents. The correct sequencing of critical activities related to daily and monthly cleaning of both primary and secondary engineering controls will be presented as well.
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Current Good Manufacturing Practices (cGMPs)
Philip Russ
120 Min
Product Id: 703558
This webinar will cover in detail the current Good Manufacturing Practices (cGMPs) regulations for pharmaceutical products. Attendees will learn how to comply with these FDA regulations and avoid pitfalls.
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Qualification Sample Size and Statistical Confidence for Pharma Process Performance Qualification (PPQ)
Marvin Iglehart
90 Min
Product Id: 703579
This webinar will discuss the requirements and general expectations for Stage 2 – Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.
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Quality System Development: Strength, Compliance and Efficiency through Value Stream Mapping
Philip Russ
60 Min
Product Id: 703490
This webinar will explain the principles of lean and value stream mapping. Attendees will learn how to apply lean concepts to continuous improvement work across the quality system.
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Batch Production Record (BPR) and Device History Record (DHR) Review and Quality Assessment
Jerry Dalfors
90 Min
Product Id: 703560
This webinar will provide the typical elements required to be included in the Batch Production Record and the Device History Record in order to accomplish a quality and cost effective review and quality assessment based on current regulatory expectations.
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Current Trends in FDA Inspections
Michael Ferrante
90 Min
Product Id: 703485
This webinar will focus on the current trends in FDA inspections and guidelines that can be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn how to prepare for an FDA inspection to avoid Warning Letters.