Simplifying Global Compliance
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
Recorded on: Aug. 1, 2019
Description: Medical device expert Michael Gaba shares best practices to get your software as a medical device (SaMD) product to market faster with the Software Precertification Program. He discusses:
- How to streamline your pre-market review;
- How to leverage information and data obtained during pre-certification; and
- How to establish a more modern and tailored approach toward software integration.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michael Gaba, partner, Holland & Knight
Recorded on: July 30, 2019
Description: Legal experts Greg Levine and Kelly Combs shares best practices for understanding the expedited FDA approval programs for drugs and devices, what it takes to qualify and how to secure the benefits to make a difference in the bottom line. They discuss:
- How to explore eligibility criteria;
- How to get clarity on program features and benefits;
- How to discover designation criteria, including data generation requirements; and
- How to understand the designation review process.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Greg Levine, partner and co-chair; Kelly Combs, partner, Ropes & Gray LLP
Recorded on: July 26, 2019
Description: Compounding expert Karla Palmer shares industry expectations from, and accelerating enforcement of, the FDA’s 2018 Compounding Priorities Plan. She discusses:
- How sections 503A and 503B of the 2013 Drug Quality and Security Act affect compounding pharmacies and outsourcing facilities, and exactly what changes have been made in the draft and final guidances;
- How best to understand what enforcement actions the FDA has taken against compounders to-date and what the future may hold in regard to Warning Letters and 483s;
- What the FDA is looking for right now in compounding inspections; 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 P.C.
Recorded on: July 25, 2019
Description: Cybersecurity expert Norma Krayem shares best practices for working with unchartered regulatory and liability risks and divulges new coping strategies to implement in the rapidly changing global regulatory landscape. She discusses:
- The cybersecurity-triggered changes in the interpretation of HIPPA;
- The DHS cybersecurity initiatives, including the Automated Information Sharing (AIS) program as they pertain to Homeland Security;
- Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms; and
- The Cybersecurity Information Sharing Act and the Protected Critical Infrastructure Information (PCII) as potential “safe harbors”.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Norma Krayem, Senior Policy Advisor, Holland & Knight LLP
Recorded on: July 23, 2019
Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:
- The legal basis of FDA records access authority;
- The types of documents commonly requested during inspections;
- The perils of emails as GxP documentation, and how to avoid them; and
- The impact of the shift to real-time electronic review of documents during inspections.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting, LLC
Recorded on: July 18, 2019
Description: Industry expert Dan O’Leary shares how the latest regulations, standards and FDA guidance documents impact the validation of production processes of medical devices with animal tissue, and the implementation of compliant systems to protect patient and user health. He discusses:
- The elements of the FDA guidance document and how they fit into the U.S. regulatory system;
- The members of the ISO 22442 rule family and how they work together;
- The upcoming changes to the ISO 22442 rule family; and
- The approach to animal tissues in the EU-MDD and EU-MDR, and the factors for implementation.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises, LLC
Recorded on: July 17, 2019
Description: Quality systems expert JP Zonnenberg and strategy expert Mike Jovanis share best practices on how to calculate anticipated benefits and savings and build a business case to justify quality transformations. They discuss:
- The framework for developing business cases;
- How to move from a cost to a value structure leveraging Quality 4.0;
- The recommendations on calculating TCO and key considerations; and
- Guidance on navigating complex organizations to get buy-in.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Jan Paul (JP) Zonnenberg, Partner, Pharmaceutical and Life Sciences Companies, PricewaterhouseCoopers; Mike Jovanis, Vice President, Vault Quality, Veeva Systems
Recorded on: July 10, 2019
Description: Technical expert Wayland Rushing shares best practices for understanding and performing appropriate Extractables and Leachables studies. He discusses:
- What they are and the special issues they pose;
- The regulatory requirements involved with ICH Q3D guideline requirements, etc.;
- What to consider when designing a Extractables and Leachables program; and
- The analytical challenges associated with Extractables and Leachables.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dr. Wayland Rushing, Director of Scientific Affairs, Eurofins
Recorded on: June 26, 2019
Description: Industry expert David B. Russell shares proven ways to ensure that all the funds allowed in CTAs are collected during financial audits. He discusses:
- How to perform financial lookbacks on open studies and those in closeout;
- How to insert language into CTAs to ensure the study sponsor/CRO provides all the necessary documentation associated with payment;
- When to do a financial audit; and
- How best to handle budget amendments.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: David B. Russell, CRCP, Director, Site Strategy, PFS Clinical
Recorded on: June 26, 2019
Description: Quality Assurance expert Susan Schniepp shares best practices on the importance of an effective CAPA system, investigational techniques used in CAPA management and how CAPA can be used to drive continuous process improvements. She discusses:
- How to establish meaningful effectiveness checks;
- How to conduct world-class investigation process overviews to help comply with regulatory requirements;
- How to use discovery through closeout for every deviation from CAPA guidelines; and
- How to understand the nuances involved in lab OOS investigations.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates
