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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.
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Webinar Training Pass
Talking About Your Product Pipeline: How FDA and SEC Regulate Life Sciences Communications
88 minutes
Recorded on: Aug. 18, 2015
Description: Attorneys Julie Tibbets and Matthew Mamak discuss and comment on the tricky issues surrounding the laws and regulations the FDA and SEC must enforce. They cover:
- 6 do's and 6 don'ts for speaking publicly about a product in development;
- 4 do's and 3 don'ts when talking with analysts and investors; and
- Examples from case studies about communication that resulted in FDA enforcement actions, SEC penalties, and investor lawsuits.
Presentation: Download the presentation
Speakers: Julie Tibbets, Partner, Alston & Bird's Food, Drug & Device/FDA Group, and Matthew Mamak, Partner, Alston & Bird's Financial Services & Products Group
Recorded on: Aug. 13, 2015
Description: Quality and compliance expert Andrew Harrison teaches how to effectively write SOPs that remove ambiguity for employees so that procedures can be followed exactly the same way, every time. Topics include:
- The balance between streamlined efficiency versus in-depth understanding;
- How good SOPs work together seamlessly;
- Systems for tracking how SOPs evolve over time; and
- How to define roles in SOPs for supervisors and operators.
Presentation: Download the presentation
Speaker: Andrew Harrison, Chief Regulatory Affairs Officer & General Counsel, Regulatory Compliance Associates, Inc.
How to Validate Computerized GxP Systems
65 minutes
Recorded on: Aug. 6, 2015
Description: Validation and compliance consultant Chrysa Plagiannos outlines a step-by-step approach to the planning, execution and reporting of computer system validation activities. She discusses:
- How to adequately manage testing resources to save time and money;
- Do's and Don'ts for good documentation practices; and
- Approaches to documenting and resolving nonconformances.
Presentation: Download the presentation
Speaker: Chrysa Plagiannos, senior validation and compliance analyst, Montrium
Europe's Compliance Plan for Medical Devices
94 minutes
Recorded on: July 30, 2015
Description: Quality and compliance consultant Vanessa Lopez provides medical device professionals with the information they need to prepare for and manage routine surveillance and unannounced notified body audits. She discusses:
- What steps to take to become EU compliant;
- How to prepare for a notified body audit; and
- The major changes in medical device CE certification related to unannounced audits and other matters.
Presentation: Download the presentation
Speaker: Vanessa Lopez, Senior Principal Quality, Regulatory and Compliance Consultant
Think Like a Clinical Trial Site Auditor
56 minutes
Recorded on: July 29, 2015
Description: Medical services consultant Pamela Nelson teaches how to look at your clinical trial from an auditor's perspective to increase efficiency and compliance. She covers:
- Key differences between auditing and monitoring;
- Strategies used by seasoned auditors;
- Going beyond the template to find and fix problems.
Presentation: Download the presentation
Speaker: Pamela Nelson, Bracane Company
Taming the Supply Chain Data Beast
58 minutes
Recorded on: July 23, 2015
Description: Data quality expert Siobhan O'Bara explains the steps necessary to ensure the quality of supply chain data and share that data with business partners. She discusses:
- How to completely comply with the 2015 DSCSA requirements;
- Tips and tricks to assure you have the correct data in the event of a recall; and
- How to thwart counterfeit versions of your products entering the supply chain.
Presentation: Download the presentation
Speaker: Siobhan O'Bara, Senior Vice President, Industry Engagement, GS1 US
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Disclaimer: The following presentation reflects the personal views and thoughts of the speaker. The content is solely for the purposes of discussion and illustration, and is not to be considered legal or regulatory advice. Speaker is providing this presentation, as is, as a service to interested parties. GS1 US shall not be liable for any consequential, special, indirect, incidental, liquidated, exemplary or punitive damages of any kind or nature whatsoever, or any lost income or profits, under any theory of liability, arising out of the use of this presentation or any content herein, even if advised of possibility of such loss or damage or if such loss or damage could have been reasonably foreseen. GS1 US reserves the right to change the material at any time.
GCP Enforcement Trends
87 minutes
Recorded on: July 21, 2015
Description: Regulatory specialist Michael Swit shares lessons learned from FDA inspections of clinical trial sponsor, sites and IRBs. He discusses:
- Trends in FDA warning letters;
- Protecting against liability; and
- How to avoid enforcement actions.
Presentation: Download the presentation
Speaker: Michael Swit, Senior Director, Legal, Regulatory, Illumina
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: July 14, 2015
Description: Quality assurance expert Susan Leister discusses the key concepts and practices that make up an effective quality management system, including the following:
- Document control processes and the use of SOPs;
- Best practices for an all-inclusive training program;
- Best practices for a comprehensive audit program (internal and external); and
- Root cause analysis tools and typical pitfalls when investigating problems.
Presentation: Download the presentation
Speaker: Susan Leister, Director of Quality Assurance, Technical Resources International
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
Recorded on: July 8, 2015
Description: CDER Director Dr. Janet Woodcock and OPS Acting Director Dr. Lawrence Yu discuss the FDA's evolving approach to pharmaceutical quality six months after the launch of the Office of Pharmaceutical Quality (OPQ). They cover:
- Why OPQ was formed
- OPQ's "One Quality Voice" value statements
- OPQ's organizational structure
- OPQ's 5 objectives
- Same quality standards for all human drugs
- Science and risk-based regulatory approaches
- Quantitative and expertise-based product quality oversight
- Integration of review, inspections, surveillance, policy and research
- Development and adoption of emerging technology
Presentation: Download the presentation
Speakers: Janet Woodcock, MD, Director, CDER; Dr. Lawrence X. Yu, Acting Director, OPS; Peter Pitts, President, Center for Medicine in the Public Interest
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.
On-the-Line Process Analytics
54 minutes
Recorded on: July 7, 2015
Description: Validation and analytics expert Paul Mason discusses benefits and pitfalls of various types of process analytics. Topics include:
- The difference between internal and external validation;
- Two different methods for internal validation and five considerations for external validation;
- How FDA's guidance suggests a shift to a "life-cycle" approach; and
- Three models of chemometric data analysis and when to use them.
Presentation: Download the presentation
Speaker: Paul Mason, Director of Science and Technology Practice, Lachman Consultant Services
This webinar has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification. Upon full completion please email customerservice@fdanews.com for certificate of attendance.