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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Webinar Training Pass
Recorded on: March 27, 2020
Description: Human behavior expert Ginette Collazo discusses the psychology of human error and how to investigate and fix problems. She covers:
- Determining when human error is a causal factor of quality and compliance issues;
- Understanding the types of human error, including intentional and unintentional errors of omission and commission; and
- Measuring human error rates by using the root cause determination tool and cognitive load tool.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ginette Collazo, CEO, Human Error Solutions
Recorded on: March 19, 2020
Description: Former FDA Commissioner Mark McClellan gives an overview of emerging trends in medical product development, including efforts to further improve development and regulatory review. He discusses:
- The overall landscape of value-based payment and delivery reforms and what you must know about their growing linkages to medical product development;
- Increasing concerns associated with the price for transformative medical technologies like gene and cell therapies, and how these anticipated prices are driving stakeholders to explore new types of contract mechanisms and alternative payment models;
- Insight into new policy development areas emerging around challenges with payer coding, coverage and payment processes for innovative medical technologies; and
- The growing need for a real-world data and evidence development infrastructure and its anticipated role in improving your development of medical products as well as regulation and care delivery.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Mark McClellan, Director and Robert J. Margolis Professor of Business, Medicine and Policy, Duke-Margolis Center for Health Policy
Recorded on: March 18, 2020
Description: The FDA’s Douglas Throckmorton discusses how the agency is currently administering the GMP requirements to be followed in the case of drug shortages. He covers:
- The pivotal role manufacturers can play in assessing potential threats to quality;
- The crucial role that data and transparency play in quality issues affecting drug shortages; and
- How drug manufacturers can stay in compliance with FDA regulations on cGMP quality.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Douglas Throckmorton, Deputy Director for Regulatory Programs, Center for Drug Evaluation and Research, FDA, and Peter Pitts, President, Center for Medicine in the Public Interest
Recorded on: March 11, 2020
Description: Device systems expert Dan O’Leary explains how to predict misuse errors and make risk management plans that comply with the revised ISO 14971:2019. He discusses:
- What you must know about the regulatory status of the standards in the U.S., EU and Canada;
- How to comply with the FDA Center for Devices and Radiological Health’s approach to usability engineering;
- How to incorporate the concepts of formative and summative evaluation; and
- Which inputs you must add to your user interface specification.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Feb. 27, 2020
Description: FDA regulatory expert Scott Lassman explains the requirements of pharmaceutical exclusivity. He discusses:
- The new standard governing the scope of 3-year clinical investigation exclusivity;
- Orphan drug exclusivity; and
- Current legislative proposals.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Scott Lassman, Principal, Lassman Law & Policy
Recorded on: Feb. 25, 2020
Description: Trade attorney Jennifer Diaz discusses strategies for resolving FDA and Customs and Border Patrol (CBP) issues. She covers:
- Analysis of important recent enforcement actions;
- Customs and Border Protection detention and seizure processes;
- Mitigating and aggravating factors in enforcement; and
- Submitting a petition for relief.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Jennifer Diaz, President, Diaz Trade Law and Diaz Trade Consulting
Recorded on: Feb. 20, 2020
Description: EU medical device regulatory expert James Pink describes the role of the Person Responsible for Regulatory Compliance (PRRC) under the new EU-MDR. He discusses:
- The relationship between the PRRC and the strategy set for regulatory compliance;
- Evaluating whether your corporate structure is ready to ensure supervision and control of products to achieve EU regulatory compliance; and
- The importance of organizational design to ensure the various roles participating in compliance are understood and coordinated.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Pink, Vice President, NSF Health Sciences Medical Devices, Europe
Recorded on: Feb. 19, 2020
Description: Quality assurance expert Susan Schniepp discusses how to streamline your audit approach so you can identify quality issues. She covers:
- How to use a risk-based approach to audits;
- Understanding the importance of quality culture and regulatory requirements identifying quality culture;
- Steps to take with the manufacturer when a quality issue is identified; and
- Best practices for documenting and tracking resolutions to identified issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Schniepp, Independent Consultant
Recorded on: Feb. 18, 2020
Description: FDA enforcement expert Karla Palmer discusses recent trends in FDA enforcement of pharmacy compounding regulations. She covers:
- Changes brought about in draft and final guidances;
- What enforcement actions the FDA has taken against compounders to date and what could lie down the road;
- What the FDA is looking for right now; and
- The interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Karla Palmer, Director, Hyman Phelps & McNamara
Recorded on: Feb. 12, 2020
Description: Quality management expert Patricia Santos-Serrao discusses how connecting quality management technologies can increase efficiency. She covers:
- How to build a robust risk management protocol that automates vital actions in other systems;
- How to optimize document controls;
- Implementing a learning management system that ensures compliance; and
- Incorporating business processes into technology to automate tasks and reduce risk of critical tasks being missed.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Patricia Santos-Serrao, Director, Product Strategy, MasterControl