Simplifying Global Compliance
The Webinar Training Pass
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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.
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!
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Webinar Training Pass
Recorded on: Nov. 7, 2018
Description: Biotech consultant Nitisha Pyndiah explains how the FDA is modernizing its biosimilars policies. She discusses:
- Interchangeability vs. biosimilarity — understanding the differences under the BPCI Act;
- The development and implementation of new FDA review tools;
- Enhancements to the Purple Book, including more information about approved biological products; and
- The significance of the BsUFA II fees.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nitisha Pyndiah, Consultant, HartmannWillner
Recorded on: Nov. 1, 2018
Description: Pharmaceutical and medical device attorney Michael Burke discusses the implications of the EMA’s upcoming move out of the UK and how resulting staffing and logistical problems may disrupt the regulator’s operations. He covers:
- Legal uncertainty regarding contracts involving both the UK and other EU member states;
- How staffing and logistical problems resulting from the agency’s move to Amsterdam may disrupt its operations; and
- The impact of the separation on international harmonization efforts.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Michael Burke, Partner, Corporate Practice, Arnall Golden Gregory
Recorded on: Oct. 30, 2018
Description: Quality management expert Dan O’Leary explains the risk-based approach to auditing featured in the latest edition of ISO 19011. He discusses:
- The seven principles of auditing;
- Differences between the 2018 and 2011 versions of 19011;
- Types of audit sampling and when to use them; and
- Evaluating auditor competence.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
Recorded on: Oct. 18, 2018
Description: Metrics experts Linda Sullivan and Keith Dorricott discuss approaches trial sponsors are taking to comply with ICH E6(R2). They cover:
- New risk-based quality management requirements described in ICH E6(R2) section 5.0;
- The importance of critical thinking in risk assessment and risk control;
- The meaning of high and low detectability and the relevance to risk prioritization; and
- Leading practices to improve risk assessment and quality oversight.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Linda Sullivan, Executive Director, Metrics Champion Consortium, and Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.
Recorded on: Oct. 18, 2018
Description: FDA compliance expert Ricki Chase digs into the details of the CDER revamp and explains how it could affect drugmakers. She discusses:
- How the Office of New Drugs is organized now and how it will change;
- What the FDA says is the goal of restructuring, and opportunities and challenges that could result;
- The specific impact on new drug application reviews; and
- How the restructuring may affect critical CDER and FDA functions.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Ricki A. Chase, Director, Compliance Practice, Lachman Consultant Services Inc.
Recorded on: Oct. 17, 2018
Description: Quality metrics experts Steven Mendivil and Denyse Baker explain the latest developments in the FDA’s quality metrics plans. They discuss:
- How the agency’s site visit pilot program is progressing and what the FDA has learned so far;
- How to take advantage of opportunities to provide input to the FDA before it drafts regulations to implement the program, including contact with appropriate agency personnel;
- The FDA’s latest draft guidance on quality metrics; and
- Major industry concerns, such as metrics selection and definitions, and how the agency is addressing them.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Steven Mendivil, Senior Advisor for Quality/External Affairs, Amgen, and Denyse Baker, Senior Policy Director-U.S. Regulatory Affairs, AstraZeneca
Recorded on: Oct. 16, 2018
Description: Regulatory expert Karla Palmer explains the FDA’s 2018 Compounding Priorities Plan. She discusses:
- How sections Secs. 503A and 503B of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities;
- Changes brought about in FDA draft and final guidances;
- What enforcement actions FDA has taken against compounders to date and what could lie down the road; 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: Sept. 27, 2018
Description: Safety reporting experts Kendra Hayden and Steven Beales point out new efficiencies in safety reporting that can help cut trial costs. They discuss:
- How to reduce a site’s reporting burden by 10 hours per week;
- Global safety reporting regulations; and
- How to maximize control over global safety reporting.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Kendra Hayden, Business Transformation Program Lead for Safety Reporting, WIRB-Copernicus Group, and Steven Beales, senior VP-IT and Market Owner of Safety Solutions at ePharmaSolutions
Recorded on: Sept. 25, 2018
Description: Attorney Kelliann Payne, a specialist in medical device regulation, explains the advantages and challenges of using the de novo pathway to device approval. She discusses:
- The differences in regulatory pathways for more novel devices;
- FDA timelines for clearance or approval of novel medical devices;
- Benefits of the pre-submission process for devices seeking de novo classification; and
- Potential pitfalls in the FDA clearance and approval process.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Kelliann Payne, Counsel, Hogan Lovells
Recorded on: Sept. 19, 2018
Description: Regulatory expert Dan O’Leary breaks down requirements for developing software for use in or with medical devices. He discusses:
- FDA guidance documents related to software;
- Interrelationships among software development, premarket submissions and postmarket activities;
- The role of ISO 14971:2007 as the overarching risk management standard;
- IEC 62304:2006 and its role as a software process standard; and
- How to determine the software safety class of a medical device.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises LLC
