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: Dec. 19, 2016

Description: Quality assurance expert Armin Torres discusses how to make sure that your data — which has come from multiple sources — is internally consistent across the full data set and with your company metrics and KPIs. Topics include:

  • How to make raw data available using the least burdensome approach;
  • How to control the cost of manual or automated data collection, review, and aggregation;
  • How to develop a process for digital data extraction, cleansing, integration, and validation prior to reporting; and
  • How to make available training and resources for data analysis, interpretation, and visualization.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Armin Torres, Principal/Senior Software Consultant, Qualified Data Systems

Recorded on: Dec. 15, 2016

Description: Regulatory expert Steven Grossman discusses the FDA’s activities under the Obama administration and what it likely will be doing under the next administration. Topics include:

  • The likelihood that the current commissioner will continue to head the agency —for how long — and who the top candidates are to replace him;
  • What the FDA’s likely priorities will be in 2017 under the new administration; and
  • How the new Congress is likely to impact what FDA does in 2017.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steven Grossman, President, HPS Group, LLC

Recorded on: Dec. 14, 2016

Description: Global drug safety expert Graeme Ladds teaches how to develop and maintain Company Core Data Sheets. Topics include:

  • Differences between Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI);
  • EU vs. U.S. interpretation of what to include in a CCSI; and
  • How and when to add to a CCSI.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Graeme Ladds, CEO, PharSafer Associates Ltd.

Recorded on: Dec. 14, 2016

Description: Systems expert Dan O’Leary explains the FDA’s QSR requirements for validation of software used in both production and the quality management system. He discusses:

  • How and why the FDA is focused on this emerging threat area;
  • The systems that need validation and revalidation; and
  • Why software validation and revalidation needs to be proportionate to the risk associated with the use of the software.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Dan O’Leary, President, Ombu Enterprises, LLC

Recorded on: Dec. 8, 2016

Description: Industry expert Robert Brooks discusses the challenges and implications of dealing with a global supply chain and the immediate need for drug makers to become more proactive. Topics include:

  • Understanding the views and requirements of worldwide regulatory bodies regarding end-to-end supply chain management;
  • Goals and deadlines of FDA, EMA and ICH regulations and guidances that will impact the management of raw materials and finished products;
  • Proven strategies for effective risk management ; and
  • Current best practices to build and maintain your supply chain.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Robert Brooks, CEO, Blewbury Brooks Consulting Limited

Recorded on: Dec. 1, 2016

Description: Process automation expert Jack Yeager discusses software solutions that streamline and automate your core business processes saving millions of dollars through improved compliance, reduced employee workload and lower operating costs. He covers:

  • Leveraging technology to help ensure submissions are completed on time, with minimal resource impact;
  • Simplifying the submission process;
  • Improving communications;
  • Anticipating resource issues; and
  • Visualizing processes and issues.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Jack Yeager, Founder, Sylogent

Recorded on: Nov. 30, 2016

Description: Regulatory expert Steve Niedelman presents real-life stories he has encountered in FDA inspections and discusses how they should have been handled. He discusses how to deal with such situations as:

  • A male FDA investigator who follows one of your female employees into the ladies room;
  • An investigator who is verbally abusive to your employees; and
  • An investigator who proposes to disassemble your roof-top HVAC unit in order to inspect it.

Presentation: Download the presentation

Transcript: Download the transcript

Speaker: Steve Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding

Recorded on: Nov. 30, 2016

Description: Life sciences strategists Alan Frederickson and Crona O’Conallain share recent research showing how risk-based monitoring can increase study quality and patient safety. They discuss:

  • The challenges to overcome while implementing an RBM approach;
  • The technology needed to implement centralized monitoring;
  • Why the distribution of data across your study sites might trigger an alarm; and
  • Key metrics that can point to poor performance and noncompliance.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Alan Frederickson, Senior Director, Technology & Automation Solutions, Data Sciences, Safety & Regulatory, and Crona O'Conallain, Senior Director Data Sciences, Safety and Reporting, QuintilesIMS

Recorded on: Nov. 29, 2016

Description: Veronica Lim, William Greenrose and Nick Sikorski of Deloitte & Touche discuss how a document hierarchy is structured to capture security requirements that align with regulations and industry leading practices. They cover:

  • How to integrate your Medical Device Security Program into your QMS;
  • The risk of not having a consolidated document hierarchy and consistent documentation of medical device cybersecurity processes; and
  • The key components to successfully implementing a medical device security document hierarchy.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Veronica Lim, Principal, Regulatory & Compliance; William Greenrose Managing Director, Advisory, Regulatory Forensics and Compliance Practice; and Nick Sikorski Senior Consultant, Advisory, Cyber Risk Services, Deloitte & Touche LLP

Recorded on: Nov. 29, 2016

Description: Recall experts Willie Bryant and Chris Harvey discuss how to assess your current recall plans to see if they’ll really work when you put them into action. They cover:

  • How to decide when a recall is required;
  • What resources you need to gather; and
  • How to communicate with the FDA.

Presentation: Download the presentation

Transcript: Download the transcript

Speakers: Willie R. Bryant, Expert Consultant, and Chris Harvey, Recall Strategist, Stericycle ExpertSOLUTIONS