Recorded on: Oct. 15, 2019

Description: Device expert Connie Hoy shares best practices for responding to nonconformities found during an audit inspection. She discusses:

• How to analyze the criticality of the audit findings;
• How to avoid complicating the corrective actions and inadvertently overburdening organizations;
• How to prioritize plans by identifying corrections and corrective actions;
• How to write a sufficient corrective action and preventive action (CAPA) procedure; and
• How to draft an appropriate response to the auditing agency.

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Speaker: Connie Hoy, Founder, Hoy & Associates Regulatory Consulting

Recorded on: Oct. 10, 2019

Description: Risk management expert Mark Levy shares best practices for having a solid process for compliance with current law and guidance in regard to medical product off-label use and marketing. He discusses:

• The current law and guidance on off-label promotion and how it affects quality, regulatory and compliance professionals;
• How to detect potential allegations of wrongdoing and how to deal with them;
• The nuances of the False Claims Act and how the First Amendment intersects with claims; and
• How to conduct an effective internal investigation when alleged unlawful off-label promotion is detected.

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Speaker: Mark Levy, Litigator and Trial Attorney, Eckert Seamans

Recorded on: Oct. 9, 2019

Description: Quality systems expert Dan O’Leary shares insights to help find solutions to the five highest-risk areas that prompt 483s and warning letters. He discusses:

• The most commonly cited section in warning letters;
• The distribution of warning letters by source, region and part;
• The Forgotten Five — the bottom 5 of the top 10 — most cited observations;
• The issues cited in the warning letters; and
• How to address the issues before inspection.

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Speaker: Dan O’Leary, President, Ombu Enterprises, LLC

Recorded on: Oct. 9, 2019

Description: Technology expert Filip Matakovic shares best practices for making a paperless transition, including how updated guidelines and new technology have lowered the hurdles and streamlined the transition to going electronic. He discusses:

• System compliance and audit readiness;
• The costs and current methodologies of paper binder storage;
• The advantages of managing documents electronically; and
• eSignatures and Part 11 compliance.

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Speaker: Filip Matakovic, Vice President and General Manager, Site Services Group, MedPoint Digital

Recorded on: Oct. 8, 2019

Description: Regulatory experts Dirk Rodgers, Susanne Somerville and Joseph Lipari share best practices for staying up-to-date on the changing pharma regulatory landscape along with VRS solutions. They discuss:

• The evolving serialization mandates for Russia, China, India and Egypt;
• Blockchain and interoperability;
• The saleable returns mandate.

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Speakers: Dirk Rodgers, Regulatory Strategist, Founder of RxTrace.com; Susanne Somerville, Chief Executive Officer, Chronicled; Joseph Lipari, Director, Cloud Products, Systech

Recorded on: Oct. 4, 2019

Description: Experts Julie Larsen and Lenita Sims-Spears share best practices for keeping abreast of the changes, and potential impact, brought by VMSR and NEST. They discuss:

• The real-world impact new medical device reporting programs will have following the formal end to the ASR program;
• How the FDA is transitioning to the VMSR program;
• Which devices and device malfunctions are eligible, or not, for summary reporting in VSMR; and
• The critical components of FDA’s NEST initiative and how the FDA will monitor medical device performance through NEST.

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Speakers: Julie Larsen, Principal Consultant and Director of Inspection Readiness Services, BioTeknica, Inc.; Lenita Sims-Spears, Senior QARA Consultant, BioTeknica, Inc.

Recorded on: Oct. 2, 2019

Description: Clinical experts Irina Petrova and Anna Yanaeva share best practices for preparing to choose the right CRO for your organization, whether they be local or globally located. They discuss:

• How to select the right CRO — Does the CRO have global reach, local regulatory expertise, brand recognition, speed of decision-making, advanced technologies and competitive pricing;
• What pharma-CRO relationships are like — Why are most pharma firms unsatisfied with their experiences;
• How to choose a CRO based on therapeutic area expertise.

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Speakers: Irina Petrova, Director of Clinical Operations; Anna Yanaeva, Director of Business Development; OCT Clinical Trials

Recorded on: Sept. 27, 2019

Description: Regulatory experts Cynthia Schnedar and Liz Oestreich share best practices for exploring the new inspections landscape of the Mutual Recognition Agreement (MRA). They discuss:

• The Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 and what it has led to;
• How inspectors are using each other’s inspections to maintain a risk-based approach, to include potential benefits for U.S. drug safety;
• How the MRA may complicate regulatory and compliance operations — which inspections will the FDA continue to perform, and which will be assigned to EU member states; and
• What’s next for FDA capability assessments and the possibility of duplicating the MRA model in other regions, including the potential impact of ‘Brexit’ on the MRA.

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Speakers: Cynthia Schnedar Esq., Executive Vice President, Regulatory Compliance; Liz Oestreich Esq., Vice President, Regulator Compliance, Greenleaf Health Inc.

Recorded on: Sept. 27, 2019

Description: Data Management expert Israel Heskiel shares best practices for compliance with FDA Data Integrity Title 21 Part 11. He discusses:

• How to communicate with IT leaders about IT’s role in data integrity compliance;
• How to establish SOPs and getting IT, QA, the Supply Chain and R&D on the same page;
• How IT, quality management and regulatory affairs can be scaled for speed and efficiency under the Final Guidance on Data Integrity and Compliance with Drug cGMP; and
• How to create an “FDA audit IT SWAT team” for continuous improvement.

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Speaker: Israel Heskiel, CEO, CIO, Agrei Consulting

Recorded on: Sept. 25, 2019

Description: Regulatory expert John Smith shares best practices about the approaches the FDA is taking in regard to AI-based image analysis. He discusses:

• How the FDA views AI within its medical device regulatory paradigm;
• The different types of computer-assisted image analysis recognized by the FDA;
• The data that the FDA expects to support AI-based CAD applications; and
• How the FDA views post-market changes to CAD algorithms.

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Speaker: John Smith, M.D., J.D., Partner, Hogan Lovells