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Classifying Medical Devices - US and EU
Charles H Paul
60 Min
Product Id: 705045
The Medical Device Classification webinar explains the classification system in US and the EU.
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Design History File (DHF), Device Master Record (DMR) and DHR Utilizing the Principles of Lean Documents and Lean Configuration
Jose Mora
90 Min
Product Id: 703373
This webinar will explain how to create, develop and manage Design History Files (DHFs), Device Master Records (DMRs), and Design History Files (DHFs) using lean document and lean configuration methods.
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How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)
Angela Bazigos
90 Min
Product Id: 705488
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
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Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity
Edwin Waldbusser
60 Min
Product Id: 705432
This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.
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Changing Supplier Controls Requirements
John E Lincoln
60 Min
Product Id: 702277
This training on FDA supplier controls will help you refine your supplier chain management and vendor audits to match the FDA's tougher position. We will evaluate the chief areas of change to see how to better prepare a supplier chain management and audit program.
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Stability and Shelf Life of Medical Devices
Stephanie Cooke
90 Min
Product Id: 705485
This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.
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Medical Device CE Mark & Quality System Certification: Recent & Proposed Changes
John Chapman
60 Min
Product Id: 700184
This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.
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Develop a Device Master Record that can assist with Device History Record Review
Mary Nunnally
60 Min
Product Id: 705328
This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.
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Statistical Concepts of Process Validation
Daniel O Leary
90 Min
Product Id: 701630
This webinar will discuss the fundamental statistical concepts to perform an effective process validation. Attendees will learn best practices to comply with QSR and ISO 13485:2016 requirements for process validation.
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Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Angela Bazigos
90 Min
Product Id: 703738
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
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Risk Based Approach in cGMP - Quality Risk Management (QRM)
Shana Dressel
60 Min
Product Id: 705412
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
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FDA Inspections: What Regulations Expect
Joy McElroy
90 Min
Product Id: 705346
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
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European Filing and Registration Procedures
Robert J Russell
90 Min
Product Id: 701261
This Regulatory compliance training is designed to provide an overview of the regulatory environment throughout Europe and will explain how the EU interacts with national regulatory agencies.
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ISO 9001 and ISO 13485 Upgrades and Impact on the Industry
Carmine Jabri
60 Min
Product Id: 705449
This webinar will focus on the recent changes to the ISO 9001 and ISO 13485 quality management system (QMS) standards. Participants will be provided with the tools necessary to help their company plan for the transition to the new editions.
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Qualification of Contract Manufacturer Organizations Based on Practical Experience
Edwin Waldbusser
60 Min
Product Id: 705384
This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.
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Acceptance Activities in FDA QSR
Daniel O Leary
90 Min
Product Id: 702267
This webinar will explain FDA QSR requirements for acceptance activities related to medical device manufacturing. It will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements.
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Reduce Inspection Costs with Sequential Sampling
William Levinson
60 Min
Product Id: 705336
This webinar will explain how to use ANSI/ASQ Z1.4 to define sampling plans including its switching rules. It will also offer an inspection plan format that reduces the sequential sampling plan to ten or fewer rows in most cases.
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FDA Import Alert - 2017
Casper Uldriks
60 Min
Product Id: 705323
This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.
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Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
Jeff Kasoff
60 Min
Product Id: 700322
This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.
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Using Open Access - Finding Trustworthy Online Resources
Anne E Maczulak
90 Min
Product Id: 705322
This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.