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Preparing for a UDI Implementation
Lena Cordie Bancroft
90 Min
Product Id: 704579
This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.
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Risk Based Design Control
Edwin Waldbusser
60 Min
Product Id: 704548
This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.
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US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Robert J Russell
90 Min
Product Id: 704587
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
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Integration of ERP and Legacy FDA-Regulated Systems
Carolyn Troiano
60 Min
Product Id: 704547
This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.
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CAPA Investigations - Tools for a Compliant and Effective Investigation Process
Carlos Rodriguez Garcia
60 Min
Product Id: 704039
This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.
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3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections
Mukesh Kumar
60 Min
Product Id: 703621
The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.
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3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products
Robert J Russell
3 hrs
Product Id: 704356
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
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Design Inputs Design Outputs Traceability Matrix - Principles of Lean Documents and Lean Configuration
Jose Mora
60 Min
Product Id: 703321
This webinar will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to these linked and cascading documents.
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How to write an effective Request for Proposal (RFP)
Joseph Winslow
60 Min
Product Id: 704417
This training program will provide tools require to understand what a good Request for Proposal (RFP) looks like, how to write one, and how the job of selecting a vendor becomes easy when these tools are employed.
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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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Using Analysis of Variance - A Practical Approach
Daniel O Leary
60 Min
Product Id: 703824
This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.
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Preparing for FDA's Unique Device Identification Rule
Daniel O Leary
90 Min
Product Id: 702594
This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.
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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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Upcoming Changes to ISO 14-644 Parts 1 and 2 - Cleanrooms and Associated Controlled Environments
Joseph Winslow
60 Min
Product Id: 704339
Attendees will come away from this training program with a good understanding of upcoming changes to the ISO standard and the implication of those changes to the classification and operation of clean rooms in regulated industries.
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How to Survive FDA's New Inspection and Enforcement Practices
Dr. Ludwig Huber
75 Min
Product Id: 704328
This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.
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FDA's Expectations from Supplier Management for GMP: Quality Agreements and More
Mukesh Kumar
90 Min
Product Id: 703483
This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.