Recorded on: June 6, 2019

Description: Quality systems expert Dan O’Leary shares pain points involved in design changes as they are related to FDA regulations. He discusses:

• The relationship among design output, design transfer and production control;
• Elements of the new UDI rule;
• The requirement to evaluate change significance for 510k submissions; and
• Implications for FDA inspections.

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

Recorded on: May 30, 2019

Description: Operational Excellence expert Dan O’Leary shares compliance and process validation procedures. He discusses:

• QSR requirements for process validation;
• ISO 13485:2016 requirements for process validation;
• Linking sampling verification to the process model; and
• Process validation’s role in risk management.

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

Recorded on: May 30, 2019

Description: Food and drug regulatory expert Pamela Forrest shares best practices for compliance with Part 806. She discusses:

• The nuances of Part 806 and when to report a recall;
• How recalls differ from enhancements;
• The handling of different classes of device recalls; and
• Enforcement actions, liability and product seizures.

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Speaker: Pamela Forrest, Partner, Food, Drug and Device Practice, Covington & Burling

Recorded on: May 29, 2019

Description: FDA legal expert Roseann B. Termini shares insights into four top issues currently being debated as new approaches to life science regulation. She discusses:

• The opioid initiative and task force;
• Guidance on the Right-to-Try law;
• Dietary supplement regulation; and
• Biosimilar development and the BPCI Act guidance.

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Speaker: Roseann B. Termini, Food and Drug Lawyer

Recorded on: May 22, 2019

Description: Regulatory experts Kalah Auchincloss, Kevin Madagan and Wayne L. Pines discuss how changes and reforms made under former FDA Commissioner Scott Gottlieb will fare under new management. They cover:

• Policy decisions on generic drug approval;
• Reorganization of the Office of New Drugs;
• Further changes in the FDA’s policies on advertising and promotion regulation; and
• Changes in FDA standards for clinical trials.

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Speakers: Kalah Auchincloss, Senior Vice President, Regulatory Compliance and Deputy General Counsel, Greenleaf Health; Kevin Madagan, Partner, Reed Smith, LLP; and Wayne L. Pines, President, Health Care, APCO Worldwide

Recorded on: May 15, 2019

Description: Technology expert Filip Matakovic shares best practices for making the transition to an electronic regulatory (eReg) binder system. He discusses:

• System compliance and audit readiness;
• Costs and current methodology of paper binder storage;
• Advantages of managing documents electronically; and
• eSignatures and Part 11 compliance.

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

Recorded on: May 15, 2019

Description: Legal expert Rachael Hunt shares best inspection practices and examines the new draft guidance on requesting FDA advice on remedying Form 483 findings. She discusses:

• Interacting with FDA investigators;
• The role of the CDRH ombudsman;
• How to respond to fallout from an inadequate response; and
• Soliciting nonbinding 483 feedback.

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Speaker: Rachael E. Hunt, Hyman, Phelps & McNamara, P.C.

Recorded on: May 9, 2019

Description: Compliance management experts Ujjal Chakravartty and Morgan Palmer share best practices for adapting to the Medical Device Single Audit Program (MDSAP). They discuss:

• Key elements of ISO 13485 and MDSAP;
• The payoff for making the MDSAP transition;
• Issues that may crop up along the way; and
• How medical device leaders are preparing for migration.

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Speakers: Ujjal Chakravartty, Director of Global Quality Systems, Avanos Medical Inc.; Morgan Palmer, Chief Technology Officer, ETQ

Recorded on: April 25, 2019

Description: FDA assistant commissioner Heidi C. Marchand reviews the final guidance on Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway. She discusses:

• Labeling indications and usage section for products approved under the Accelerated Approval pathway;
• Product approvals based on a surrogate or intermediate clinical endpoint and inclusion in the product label;
• Revising the indications and usage section on verification of clinical benefit from postmarketing studies;
• Referencing postmarket study requirements for continued approval of the indication; and
• Withdrawals of an accelerated approved indication and removals of information about the withdrawn indication from the labeling.

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Speaker: Heidi C. Marchand, Assistant Commissioner, Office of Health and Constituent Affairs, Office of External Affairs, Office of the FDA Commissioner

Recorded on: April 24, 2019

Description: Consultant Nancy Reynolds Howard tackles the nuances and best practices for optimizing reimbursement of clinical trial services. She discusses:

• The relationship between documentation of medical necessity and billing compliance;
• The enhancement of billing compliance using medical necessity language and document consistency reviews;
• The connection between the language used in the informed consent form and billing compliance;
• The nuances of specific codes and modifiers for claims under Medicare’s clinical trial policy and investigational medical device regulations; and
• The importance of complying with Medicare diagnostic and procedural codes.

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Speaker: Nancy Reynolds Howard, Consultant, NRH Compliance Partners