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: Feb. 20, 2019
Description: Regulatory expert Mary Vater shares best practices for preparing and submitting 510(k) applications as FDA policies evolve. She discusses:
- What specific changes the FDA has made to the 510(k) process;
- How to identify a suitable and favorable predicate device;
- How the FDA is addressing the changing biocompatibility requirements; and
- The best time to file your pre-submission.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Mary Vater, Medical Device Consultant, Medical Device Academy, Inc.
Recorded on: Feb. 19, 2019
Description: Attorney and pharmacist Lee Rosebush addresses newly proposed standards for outsourcing. He discusses:
- Implementing best practices to protect against contamination;
- Ensuring that a compounder conducts sterility assurance activities for sterile products and microbiological quality activities for non-sterile products; and
- Conducting annual quality standard evaluations of drug products.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Lee H. Rosebush, Partner, Baker Hostetler
Recorded on: Feb. 14, 2019
Description: Regulatory experts Nicholas Mitrokostas and Daniel Orr discuss recent developments in regulation of biosimilars. They cover:
- Modernizing policies governing the development of biosimilars to make it more efficient;
- Educating clinicians, payers and patients about biosimilar products and the rigorous evaluation they must go through; and
- Modernizing regulatory policies to accommodate new scientific tools that better enable comparison between biosimilars and reference products that may reduce the need for clinical studies.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Nicholas Mitrokostas, Partner, Goodwin Procter LLP, and Daniel Orr, Partner, Womble Bond Dickinson LLP
Recorded on: Feb. 13, 2019
Description: Supply chain consultant Evren Ozkaya explains how to prepare for upcoming serialization and track-and-trace requirements. He discusses:
- Lessons learned from the first five years of implementation of the Drug Supply Chain Security Act;
- How to setup the right foundation for digital supply chain management; and
- New technologies (e.g., Blockchain, Internet of Things) that will define supply chain capabilities.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Evren Ozkaya, Founder & CEO, Supply Chain Wizard, LLC
Recorded on: Jan. 30, 2019
Description: Regulatory expert James Rogers explores the nature and regulation of software as a medical device (SaMD). He discusses:
- The process for classifying an SaMD based on U.S. and international guidance;
- How a company’s use of a software product impacts the classification of SaMD;
- When a purchased software product becomes an SaMD; and
- Remediation approaches to resolve SaMD compliance issues.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: James Rogers, Founder, Compass Life Science Solutions
Recorded on: Jan. 29, 2019
Description: Regulatory expert Tiffany Guckin explains the nature and content of investigator’s brochures (IB) and IND annual reports. She discusses:
- The importance of annual reports to the FDA and sponsors;
- Structure and content of an IB per ICH E6 (R2);
- How to ensure you are accurately representing your investigation to potential subjects; and
- Best practices that can be included in SOPs or other regulatory processes.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Tiffany Guckin, Associate Director of Regulatory Affairs, Invicro
Recorded on: Jan. 17, 2019
Description: Regulatory expert Keith Webber discusses new ICH guidances being developed. He covers:
- The nuances in global harmonization of the biopharmaceutics classification system for requesting biowaivers under ICH M9;
- What to expect for the global harmonization of bioanalytical method validation under ICH M10; and
- Why the ICH Q12 guideline is a game-changer for pharmaceutical regulatory and quality professionals.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Keith Webber, Vice President of Biotechnology, Lachman Consultant Services, Inc.
Recorded on: Jan. 15, 2019
Description: Cybersecurity expert Norma Krayem discusses the rapidly changing global IT security regulatory landscape. She covers:
- Cybersecurity-triggered changes in the interpretation of HIPAA and enforcement by the HHS Office of Civil Rights;
- Cybersecurity as an enterprise risk management issue affecting security, risk and privacy functions in device firms;
- FDA’s evolving focus on cybersecurity and how it impacts the risk, responsibilities and regulation of companies; and
- The Cybersecurity Information Sharing Act (CISA) 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 and Co-Chair, Cybersecurity and Privacy Team, Holland & Knight
Recorded on: Jan. 10, 2019
Description: GMP expert Dan O’Leary explains how to collect samples of records for an audit. He discusses:
- Concepts of sampling applied to quality audits;
- The difference between a nonconformance and nonconformities;
- The use of (non-statistical) convenience samples; and
- The role of the binomial distribution in audit sampling.
Presentation: Download the presentation
Transcript: Download the transcript
Speaker: Dan O’Leary, President, Ombu Enterprises
Recorded on: Dec. 18, 2018
Description: Attorneys Stephanie Resnik and Christopher Hanson outline the FDA’s new medical device voluntary malfunction disclosure program. They discuss:
- How the program differs from individual malfunction reporting;
- How the program will help increase devicemakers’ efficiency; and
- Conditions under which the program is not available to manufacturers.
Presentation: Download the presentation
Transcript: Download the transcript
Speakers: Stephanie Resnik and Christopher Hanson, Associates, Covington & Burling LLP, Washington, DC
