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The New EU Clinical Trial Regulation
Robert J Russell
90 Min
Product Id: 703758
This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.
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Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)
Peggy Berry
90 Min
Product Id: 704882
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
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USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP
Gregory Martin
90 Min
Product Id: 703521
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.
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Effective Annual U.S. FDA CGMP Training
John E Lincoln
60 Min
Product Id: 701136
This FDA Compliance training will be helped to see how to develop, maintain and improve on a compliant CGMP Employee Training Program for their particular company, product line, and culture.
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Problem Solving using DMAIC
Mercedes Massana
60 Min
Product Id: 704807
This webinar will provide an introduction into the DMAIC problem solving process and will show how DMAIC can be utilized to ensure that any process which requires an investigation to be performed can be thoroughly addressed and well documented.
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Creating the ISO 14971:2007: Developing the Risk Management File
Daniel O Leary
90 Min
Product Id: 704855
This presentation gives you the essential information you need to write a successful plan. Many companies try to implement Risk Management using an inadequate Risk Management Plan. They often leave out required items or add additional, but unnecessary information. The Risk Management Plan is key to an efficacious project to ensure your device is safe and meets the regulatory requirements.
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Learning Design Controls through review of FDA 483 Observations
Mercedes Massana
75 Min
Product Id: 704805
This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.
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Simulation and Monte Carlo Analysis
Daniel O Leary
90 Min
Product Id: 704856
Simulations and Monte Carlo methods are powerful tools in quality improvement. They can help explore proposed changes to methods and processes and avoid potential problems. They can also help optimize QMS activities. In this presentation, attendees learn methods in Excel, which means that projects do not need special purpose and expensive software packages.
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Biological Indicators for Sterilization Performance Qualification
Aaron Mertens
90 Min
Product Id: 704879
This webinar will focus on biological indicator usage for sterilization performance qualification in the pharmaceutical and biotech industry. Biological indicator preparation, including population and D-value resistance determination, is presented in depth. Understanding these details is critical to successfully choose a biological indicator and qualify a sterilization process.
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Regulation of Natural Health Products in Canada
James Russell
90 Min
Product Id: 704044
This training program will discuss regulations that impact Natural Health Products in Canada. It will detail how to verify the products’ compliance with published regulations. It will also detail requirements for registration, labeling and acceptable marketing claims.
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Objections to Agile and what you can do about them?
Brian Shoemaker,Nancy Van Schooenderwoert
60 Min
Product Id: 704872
This webinar will review the classic objections to Agile practices and explain how to overcome them. We will discuss real-world examples of medical device companies currently employing Agile approaches and understand how you or your company can gain similar benefits.
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Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Henry Urbach
60 Min
Product Id: 702634
This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.
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Steam Sterilization Microbiology and Autoclave Performance Qualification
Aaron Mertens
90 Min
Product Id: 704850
This webinar will discuss the regulatory and GMP requirements for steam sterilization and the mechanism as it relates to bacterial cells and endospores. The training will cover autoclave performance qualification studies and the tools to be used.
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FDA Regulation, 3D Printing and Medical Devices
Rachelle D Souza
75 Min
Product Id: 704846
This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.
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Extractables and Leachables - Biopharma Polymeric Devices
Mark Trotter
90 Min
Product Id: 704798
This webinar training will examine the key topics concerning the use of polymeric single-use products in biopharm processes. It will offer a basic understanding of industry standards and regulatory compliance. The training program is designed for the experienced as well as those new to biopharmaceutical processes and need to know current requirements for determination of extractables and leachables in biopharm processes.
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Managing SOP Compliance per FDA Regulations
Danielle DeLucy
60 Min
Product Id: 704797
This training program will discuss formatting SOPs, FDA expectations for written documents and regulatory requirements, and the roles and responsibilities of authors and reviewers of SOPs. The program will also overview how to ensure a system for the control, archival, and disposal of written procedures.
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DMR & DHR - What Is Really Required
Daniel O Leary
90 Min
Product Id: 701861
This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). You will learn what to keep in each record and organize them to help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action.
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Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics
Rajesh Gupta
60 Min
Product Id: 704755
This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.
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Renovation of Aging Aseptic and Biological Facilities
Erich Bozenhardt
60 Min
Product Id: 704789
In this training program, attendees will explore modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years. These upgrades can also make facilities more compliant, cut down on operating risks, and improve performance.
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Preparation for GMP Inspections by Regulatory Agencies
Peggy Berry
90 Min
Product Id: 704843
This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.