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Biological Facility Design: Design for Compliance
Erich Bozenhardt
60 Min
Product Id: 704576
This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.
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Extractables and Leachables Testing for Polymeric Materials Used in Pharmaceutical Industry: An Introduction and Strategies in Current Practice
Armin Hauk
60 Min
Product Id: 704340
This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.
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FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection
Thomas Webster
2 hrs
Product Id: 704559
This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.
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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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4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.
Norma Skolnik
4 hrs
Product Id: 704530
The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.
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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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Educating and Training Staff to Manage Regulatory Records
Charlie Sodano
60 Min
Product Id: 704493
This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.
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GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry
Angela Dunston
90 Min
Product Id: 704454
This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.
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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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How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment
Michael Levin
60 Min
Product Id: 704274
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
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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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Pharmaceutical Water Use and Monitoring
Igor Gorsky
150 Min
Product Id: 704336
This training program will guide attendees on how to best deliver water from a high purity water distribution system. Attendees will learn to capitalize on the advantages of online analytical instrumentation and understand the value of rapid microbiological methods. The program will also offer an understanding of real-time release of water.
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Introduction to the FDA and Your First FDA Meeting
Andrew S Verderame
60 Min
Product Id: 704338
This FDA training program will guide attendees on how to get the best advice from FDA with the proper actions before, during and after your FDA meeting.
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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.