The Webinar Training Pass

Now get all the training you need – all in one place, and all for one low price!

The FDAnews Webinar 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.

PLUS, subscribers get automatic access to all our new training programs for the next 12 months – that’s more than 50 new programs a year!

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.

Select 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

Description: Regulatory affairs expert Mary Swift shares the secrets of a leading industry insider to get your recall done right the first time. She covers:

  • Proven ways to communicate critical information before, during and after the recall;
  • How to update authorities/governing bodies in a proactive way to best protect patients and your company;
  • How to address key logistical issues and recall strategies to fix the situation right and fix it fast; and
  • The tools and tactics to quickly and accurately determine the true scope of the recall.

Presentation: Download the presentation

Speaker: Mary Swift, Senior Manager, Regulatory Affairs, Terumo Cardiovascular Systems

 

Description: Device regulatory experts Beth Bierman, Phoebe Mounts and Michele Buenafe present a flow chart that helps compare the old and the new classification and reclassification process, including identification markers for the different steps so that manufacturers may have the ability to influence the process.

Presentation: Download the presentation

Handout #1: Download handout #1

Handout #2: Download handout #2

Speakers: Beth Bierman, Partner, Phoebe Mounts, Partner, and Michele Buenafe, Associate, Morgan Lewis FDA Practice.

 

Description: Auditing specialist Joseph McMillian navigates the complexities of the global labeling audit process and discusses common problems experienced by drug and biologic companies. Topics covered include:

  • Training auditors to look for positive and negative findings;
  • Establishing risk-based audit priorities; and
  • Proven tips and tricks for writing audit reports and proper follow-up.

Presentation: Download the presentation

Speaker: Joseph McMillian, President, Heartland Consulting

 

Description: Analyst Matthew Littlefield discusses the limitations of traditional communication methods and provides new benchmark survey data, real-world case studies and proven ways to improve collaboration with outsourced manufacturers, suppliers and partners. Topics include:

  • Top trends in document management and their role in effective quality management processes and supplier collaboration;
  • Three business process changes that help support supplier collaboration in quality processes;
  • Five must-have document management capabilities for successful supplier collaboration; and
  • Why companies that collaborate with suppliers using a cloud-based portal increase supply chain delivery performance.

Presentation: Download the presentation

Speaker: Matthew Littlefield, president and principal analyst, LNS Research

 

Description: International auditing consultant Joseph McMillian teaches drug and device manufacturers how to audit their own promotional operations before the FDA or an international regulatory body catches them in the wrong. He covers:

  • A four-step process for training staff to spot compliance problems;
  • Why audits are necessary and the legal, regulatory and ethical basis for them;
  • Tips for preparing booth staff regarding communications with attendees; and
  • Understanding what constitutes a "significant" violation that should be pointed out to on-site management immediately.

Presentation: Download the presentation

Handout: Convention Audit Checklist

Speaker: Joseph McMillian, President, Heartland Consulting

 

Description: Quality and compliance expert Albert Ghignone, CEO of AAG Incorporated, demonstrates proven tactics for requesting, preparing for and conducting FDA Pre-Submission Program meetings. He will cover:

  • How to prepare an effective pre-submission package to submit to the agency in advance;
  • How to understand and prepare for the different types of pre-submission meetings, including insight on which type to request and how to support that request; and
  • The most effective way to request, prepare for and conduct all varieties of pre-submission meetings.

Presentation: Download the presentation

Handout: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff

Speaker: Albert Ghignone, CEO, AAG Incorporated

 

Description: CDRH's M. Isabel Tejero outlines the FDA's focus on controlling supplier quality, including:

  • Common issues that appear in inspections;
  • How suppliers should meet their client manufacturer's requirements; and
  • Supplier assessment methods devicemakers can use.

Presentation: Download the presentation

Speaker: M. Isabel Tejero, Acting Lead, Quality Systems Working Group, Division of Manufacturing and Quality, Office of Compliance, CDRH, FDA

Description: Device regulatory expert John Avellanet analyzes FDA 483s and warning letters issued in 2013 and points out how devicemakers can learn from others' mistakes when it comes to dealing with suppliers. He covers:

  • The most commonly cited violations;
  • Key documents to have ready for FDA investigators; and
  • Typical questions investigators ask about supplier qualification and management.

Presentation: Download the presentation

Speaker: John Avellanet, Principal Consultant, Cerulean Associates

Description: Noted food and drug legal expert Alan Minsk explains why it is important to have a strong quality agreement with suppliers and contractors. He discusses:

  • FDA enforcement trends;
  • Tips and tools for developing quality agreements; and
  • Who is ultimately responsible – manufacturer or supplier – for maintaining compliance with quality standards.

Presentation: Download the presentation

Speaker: Alan Minsk, Partner and Leader, Food and Drug Practice Team, Arnall Golden Gregory LLP

Description: Medical device quality expert Jackie Torfin presents a new strategy for supplier qualification based on quantitative risk assessment. She covers:

  • Areas of competency the tool is designed to assess;
  • Various ways to implement the assessment tool; and
  • A real-life case study that demonstrates how the tool works.

Presentation: Download the presentation

Speaker: Jackie Torfin, Vice President of Quality, Heraeus Medical Components