Implementing the New Usability Engineering Standard
Daniel O Leary
90 Min
Product Id: 704894
Usability Engineering has become a major topic. The current standard tightens the linkage to risk management. In addition, there are changes in the US and EU approach, all of which find a basis in this standard. Attending this presentation provides the information you need to prepare for these major changes.
Validation Master Planning - The Unstated Requirements
John E Lincoln
90 Min
Product Id: 704292
This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.
Creating Effective SOPs for Regulatory Compliance
Henry Urbach
60 Min
Product Id: 702999
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements
Howard Cooper
4 hrs
Product Id: 704915
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.
The FDA Compliance Enforcement Process
David L Chesney
90 Min
Product Id: 704913
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
eLabeling for Medical Devices: Valuable but not easy
Daphne Walmer
90 Min
Product Id: 704912
This webinar will explore the benefits of internet-based manuals/IFUs (instructions for use), as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.
Integrating ISO 14971 Risk Analysis into the Product Development Process
Russell Pizzuto
90 Min
Product Id: 704926
This Webinar will present the best practices for integrating medical device risk analysis into a quality system. This integrated processes spans new product development, design change, production, and post market surveillance for the lifecycle of the device. Objective evidence produced by the integrated processes can be used to demonstrate risk analysis compliance to 21 CFR 820 and ISO 14971 during an audit.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Comparing the Pharmaceutical and Medical Device Product Lifecycles
Howard Cooper
120 Min
Product Id: 704853
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.
Understanding the Full Realm of Product Liability
Randall Goodden
60 Min
Product Id: 704743
This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.
ISO 9001:2015 Transition Overview
Kevin Gholston
90 Min
Product Id: 704781
The new ISO 9001:2015 requires companies to establish context of the organization and utilize this perspective along with the new High Level Structure (HLS) Clauses. This webinar is designed for quality assurance managers, management representatives, ISO 9001 implementation teams, and quality management system auditors. With the release of ISO 9001:2015 in September 23, 2015, now is the time to prepare. This 9001-2015 Transition Overview course will highlight the changes from the ISO 9001:2008 revision.