The Webinar Training Pass

The Training Pass program gives you year-round unrestricted access to any of the hundreds of webinars listed below. These training programs, feature top consultants, expert speakers and FDA officials.

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.

Many of our webinars have been pre-approved by RAPS as eligible for up to 1.5 credits toward a participant’s RAC recertification. Please enter keyword RAPS below for a list of eligible on-demand webinars.

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Webinar Training Pass

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.

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

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

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

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

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

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

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

Recorded on: Jan. 27, 2016

Description: Supplier management expert Steven Sharf outlines the critical components of an effective supplier quality agreement. He also discusses:

  • The importance of clearly defined roles in the complaint handling/adverse event reporting process;
  • The need for a responsibility matrix to clearly identify what entity is responsible for which quality function; and
  • Whether you should allow suppliers to use subcontractors.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steven Sharf, Senior Consultant, Validant