Recorded on: Feb. 27, 2019

Description: Regulatory experts Bethany Hills and Aaron Josephson outline the FDA’s evolving compliance policies for devicemakers. They discuss:

• What areas the FDA targeted in inspections in 2018 and has focused on for enforcement in 2019;
• The nuances in compliance areas that create risk and should be closely monitored in your quality system; and
• Enforcement tools the FDA will be using in 2019 to ensure compliance.

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Speakers: Bethany J. Hills, Chair, FDA Practice, Mintz Levin, and Aaron Josephson, Senior Director, Mintz Levin

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.”

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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.

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Speaker: Dan O’Leary, President, Ombu Enterprises