Simplifying Global Compliance
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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.
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Webinar Training Pass
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
Recorded on: Nov. 17, 2016
Description: Device expert Dan O’Leary demonstrates how an effective system for production equipment can improve device manufacturing, support a low-cost approach and improve equipment operator safety. He discusses:
- Quality management system requirements in QSR, ISO 13485:2003, and ISO 13485:2016;
- How to incorporate calibration requirements into production equipment maintenance
- Maintenance strategies and their application, including time-based, activity-based, and reliability-centered maintenance; and
- Classical equipment effectiveness metrics.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Nov. 9, 2016
Description: Life sciences attorney Katy Van Pelt offers advice on how to facilitate communication between the regulatory affairs and sales group. Topics include:
- Establishing a marketing review team, composed of sales and marketing, legal, and regulatory professionals that understand each other’s objectives and success standards;
- Understanding how the latest compliance mandates intersect with current social media and traditional marketing approaches; and
- Avoiding regulatory problems caused by the use of unapproved, non-compliant promotional materials by ensuring that your sales force gets the materials they need when they need them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Katy Van Pelt, Partner, Potomac Law Group, Regulatory, Food & Drug, Healthcare, and Life Sciences Group
Recorded on: Oct. 31, 2016
Description: Veteran FDA consultant John Lincoln explains the revised ISO 13485’s focus on software verification and validation and outlines the FDA's preferred 11-element documentation model and how to apply it to different situations. Lincoln addresses:
- What the FDA accepts as an appropriate documentation model;
- New expectations for process and testing software; and
- When and how to use DQ, IQ, OQ, PQ or their equivalents.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: John Lincoln, Principal, J.E. Lincoln and Associates LLC