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The FDAnews Webinar Training Pass program offers year-round, unrestricted access to any of the hundreds of webinars listed below. These training programs feature thought leadership and best practices from top consultants, expert speakers and current and former FDA officials. New webinars are offered every month, along with access to the Webinar Training Pass archive.
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If you are already a Training Pass member, login below and then scroll down to view the list in date order or narrow your search by keyword or category. Viewing the webinar is easy… simply identify the webinar you want to watch, click on the title and the video will begin. If you would like to view or download the presentation materials separately from the video, click the "Download Presentation" link.
Also available: Take advantage of our multi-user and site licenses of the Webinar Training Pass, so you’ll have the most-informed workforce! Contact Russ Titsch, Business Development Director at russ.titsch@wcgclinical.com or +1 703.538.7651 to receive a custom quote.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
If you have any questions or are having any problems please give us a call on 703.538.7600 or email customer service.
Webinar Training Pass
Supplier Quality Management
83 minutes
Description: GMP consultant Steven Sharf explains how to address the risks associated with accepting suppliers’ certificates of analysis through regular auditing. Topics include:
- Using risk management tools to determine which suppliers to audit;
- Audit frequencies and schedules;
- Qualifying suppliers for reduced testing; and
- Tailgate sampling.
Presentation: Download presentation
Speaker: Steven Sharf, President, GMP Concepts
Medical Device Quality Audits
92 minutes
Description: John Gagliardi of Midwest Process Innovation LLC interprets the audit requirements contained in the one-paragraph Section 820.22 of the Quality System Regulations, discussing:
- Creating a master audit schedule;
- Establishing the scope of the audit;
- Training personnel for inspections; and
- Auditor qualifications and responsibilities.
Presentation: Download presentation
Speaker: John Gagliardi, President, MidWest Process Innovation LLC
Designing & Executing Observational Studies
72 minutes
Description: Clinical trial data specialist Peggy Schrammel demonstrates how to use patient registries to collect real-world effectiveness and safety data. Topics include:
Considerations for registry design;
- Finding the most suitable data source/approach;
- Using chart review studies to capture data retrospectively; and
- Building effective registry teams.
Presentation: Download presentation
Speaker: Peggy Schrammel, VP-Registries and Post Approval Development, United BioSource
Electronic Health Records and REMS
96 minutes
Description: PDR Network CEO Edward Fotsch discusses the transition to electronic health records as required by 2010 healthcare reform legislation. Fotsch covers:
- How EHRs can cut the time and cost of communicating REMS elements;
- Incentives the law provides for hospitals and providers, and penalties for those that don’t make the switch by 2015;
- Information flow from drugmakers to providers through EHRs; and
- Potential opportunities and liabilities.
Presentation: Download presentation
Speaker: Edward Fotsch M.D., CEO, PDR Network LLC
Description: Regulatory specialists Joan Antokol and John McLane examine the FDA guidance, “Safety Reporting Requirements for INDs and BA/BE Studies,” issued in draft form in 2010 and finalized in December 2012. Topics discussed include:
- Differences in requirements for IRBs, sponsors and investigators;
- Clarification of terminology in FDA regulations prior to 2010; and
- Product liability risks.
Presentation: Download presentation
Handout – Drug Withdrawls In The US
Speakers: Joan Antokol, Managing Partner, Park Legal LLC and Dr. John (Jack) McLane, COO, Clinquest Inc.
Reduce Supply Chain Risks
85 minutes
Description: Former top FDA investigator Martin Browning examines best practices for making outsourcing decisions and navigating FDA regulations. Topics include:
- Selecting suppliers with compatible standards and principles;
- Providing information on suppliers to the FDA;
- Contracts and Service Level Agreements; and
- Continuing improvement of a supplier management system.
Presentation: Download presentation
Speaker: Martin Browning, Founder and President, EduQuest
Description: Quality assurance expert Jim Darnell explains how to negotiate, draft, implement and audit supply quality agreements with warehouses and shippers. Darnell discusses:
- How to accommodate the complexity of the warehousing and logistics process in a quality agreement;
- Special considerations, such as cold chain control and handling controlled substances;
- How to define metrics and monitoring methods.
Presentation: Download presentation
Speaker: Jim Darnell, Managing Consultant, Tunnell Consulting
Description: Expert statistician Robert Thiel offers step-by-step instruction for using the Bayesian statistical method in device clinical trials. Thiel covers:
- How the Bayesian method differs from the more commonly used Frequentist approach;
- Benefits and costs of using the Bayesian method;
- Basic probability laws; and
- Examples of the method’s practical application.
Presentation: Download presentation
Speaker: Dr. Robert Thiel, Founder and CEO, THIEL Statistical Consultants
Structured Product Labeling
68 minutes
Description: Information management expert Antoinette Azevedo explains FDA requirements for Structured Product Labeling and offers strategies for compliance. Azevedo covers:
- Data sharing using SPL;
- Information workflow; and
- echnology requirements and timeline for establishing an SPL system.
Presentation: Download presentation
Speaker: Antoinette Azevedo, Founder, e-SubmissionsSolutions.com
Medical Device Supplier Audits
79 minutes
Description: FDA insider Steven Niedelman explains the FDA’s regulations for overseeing suppliers and how to ensure outsourced operations maintain compliance. Topics include:
- Ways to evaluate, audit and select potential contractors;
- What to include in a supplier contract;
- Risk-based auditing of current suppliers; and
- Corrective action planning.
Presentation: Download presentation
Speaker: Steven Niedelman, Senior Consultant, Crowell & Moring LLP