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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.
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.
Search by keyword, speaker name or just by category (drug, device or clinical) and you'll find all you need.
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Webinar Training Pass
First Cycle Approval of ANDAs
79 minutes
Recorded on: March 23, 2016
Description: Drug application expert Aloka Srinivasan provides an overview of how to organize an ANDA to make first-cycle approval a reality. She covers:
- The best ways to communicate with the Office of Generic Drugs;
- The best ways to prepare for meetings with the FDA, if granted; and
- Complex generics and the challenges facing the industry.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Aloka Srinivasan, Principal Consultant, PAREXEL
Pharma Strategies in Latin America, Part I
95 minutes
Recorded on: March 15, 2016
Description: Global regulatory affairs specialists Fernando Ferrer and Silvia Bendiner outline the business and regulatory environment in Latin America and provide situation analysis and strategies for organizations seeking sustained growth in life-science markets. They discuss:
- Key regulating bodies in Latin America;
- Growth markets and emerging markets in the region;
- Economic outlook in various countries; and
- GMP requirements.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Fernando Ferrer, Head of Global Consulting in Business and Operations, Multinational Partnerships, LLC and Silvia Bendiner, Director of Regulatory Affairs for Latin America, Mapi Group
Recorded on: March 10, 2016
Description: Noted process analysts Herman and Erich Bozenhardt discuss the FDA’s new guidance on emerging manufacturing technology applications. They cover:
- How to participate in the FDA’S new early engagement program;
- Four classes of technology innovations; and
- Renovation to remediate bioburden, cross contamination, and containment.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Herman Bozenhardt, President, Bozenhardt Consulting Services, LLC and Erich Bozenhardt, Process Group Lead, Integrated Process Services, Inc.
Fixed-Dose Combination Drug Development
64 minutes
Recorded on: Feb. 29, 2016
Description: Regulatory specialist Ravi Harapanhalli reviews the current climate for fixed-dose drug combinations and challenges for their developers. He discusses:
- Pre-formulation, formulation, and analytical challenges and strategies associated with fixed-dose combination products;
- Technical challenges associated with developing fixed-dose combination products for various routes of administration; and
- Current and likely future of the regulatory scheme for developing fixed-dose combination products.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ravi Harapanhalli, Principal, FDAPharma Consulting
Environmental Controls for Devicemakers
91 minutes
Recorded on: Feb. 25, 2016
Description: Quality systems expert Dan O’Leary interprets FDA regulations for managing environmental conditions in device manufacturing. He discusses:
- Environmental conditions that could affect product quality;
- Linkage to other requirements, such as contamination control and buildings;
- Correction and corrective action related to environmental controls; and
- Sampling plans for environmental control and monitoring.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, Ombu Enterprises, LLC
CDRH Enforcement Trends
95 minutes
Recorded on: Feb. 25, 2016
Description: Compliance expert John Avellanet examines recent trends in CDRH’s Quality System Regulation enforcement and looks ahead to possible future activity. He discusses:
- Predictions for 2016 and 2017;
- FDA enforcement focus points for 2016 and their business implications; and
- How to prepare your compliance program for a new wave of enforcement initiatives.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Avellanet, Founder, Cerulean Associates, LLC
Developing Innovative Approaches to Postmarketing Safety Data Collection in Pregnant Women
73 minutes
Recorded on: Feb. 24, 2016
Description: Pregnancy exposure specialist Cathy Sigler talks about ways to collect data on pregnancy with the focus on birth outcomes following in utero exposure to medicinal products. She discusses:
- The need for such data;
- Regulations and guidance; and
- Key outcomes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Cathy Sigler, Senior Epidemiologist, United Biosource Corporation
Leveraging Social Media in Pharma
55 minutes
Recorded on: Feb. 16, 2016
Description: Social media experts John McDaniel and Phil Baumann discuss how social media can be mined for information about adverse events. Topics include:
- The components and detail of structuring data into meaningful elements;
- The different approaches between monitoring HCP and consumer conversations;
- Technological considerations; and
- Best practices for monitoring and interacting on social media platforms.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: John McDaniel, Senior Director, and Phil Baumann, Social Media Strategist, C3i Healthcare Connections
FDA's Device De Novo Reclassification
80 minutes
Recorded on: Feb. 9, 2016
Description: Attorneys and medical device regulatory specialists Yarmela Pavlovic, Kelliann Payne and Lina Kontos explain the de novo procedure and tell you what you must do to ensure that your request includes all the data elements and supporting research the FDA requires. They discuss:
- FDA's evolving view of substantial equivalence and de novo reclassification;
- Making effective risk/benefit arguments that will pass FDA muster; and
- What happens after an initial de novo clearance, both for subsequent modifications and for competitive products in the same classification.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Yarmela Pavlovic, Partner, Kelliann Payne, Counsel, and Lina Kontos, Counsel, Hogan Lovells US, LLP
Responding to an OPDP Titled/Untitled Letter
64 minutes
Recorded on: Jan. 29, 2016
Description: Regulatory and pharmaceutical counselor Darshan Kulkarni offers guidance on how to respond to enforcement activities of the FDA Office of Prescription Drug Promotion. He discusses:
- Recent trends in OPDP enforcement;
- Whether you should always respond to an enforcement action;
- The time frame for and goal of your response;
- What should be included in the response and what should be left out; and
- How to determine when do you need outside help.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Darshan Kulkarni, FDA Regulatory & Compliance Attorney, Kulkarni Law Firm