Recorded on: Nov. 12, 2019

Description: Clinical research experts Kerry Dyson and Kris O’Brien share real-world case studies that show how patient engagement leads to successful data capture and better outcomes. They discuss:

• How to approach project planning for the best outcomes in patient participation;
• Case studies of successful patient engagement during actual trials;
• Viewing patients as research partners and the steps needed to keep them involved; and
• Sustaining engagement and motivation throughout a trial.

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Speakers: Kerry Dyson, Global Head of Clinical Research; Kris O’Brien, Vice President of Client Strategy and Development; CROMSOURCE

Recorded on: Nov. 5, 2019

Description: Design control statistical expert Steven Walfish shares best practices for understanding the requirements for statistical techniques and how they impact the design control process and sample size issues. He discusses:

• How to appreciate the nuanced interpretations of 21 CFR 820.250;
• How to recognize the differences between confidence and reliability in the sample size;
• How to understand the importance of how data is collected and how to justify the sample size;
• How to incorporate statistical assumptions as part of all sampling plans; and
• How to grasp how variance in the population impacts the sample size necessary to establish objective evidence.

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Speaker: Steven Walfish, president, Statistical Outsourcing Services

Recorded on: Oct. 31, 2019

Description: Human error reduction expert Ginette Collazo shares best practices for minimizing human error and regulatory citations in manufacturing. She discusses:

• How to prepare an outline and develop world-class SOPs;
• The interrelationship between SOPS, quality and regulatory compliance;
• Why human error is a root cause for lack of quality and how to minimize it; and
• How to create and maintain a procedure that minimizes human error.

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Speaker: Ginette Collazo, chief executive officer, Human Error Solutions

Recorded on: Oct. 30, 2019

Description: Technology experts Jon Carter, Catie Roland and Mark Tomlinson share the differences between EDC and eSource and offer guidelines to help select solutions that suite clinical trial needs. They discuss:

• Pros and cons of EDC vs. eSource;
• The challenges of eSource adoption and pitfalls to anticipate and avoid;
• When should EDC and/or eSource be implemented; and
• Should EDC and eSource be combined in the same study.

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Speakers: Jon Carter, Product Manager; Catie Roland, Program Manager; Mark Tomlinson, Senior Director of Technology Operations; Cmed Technology

Recorded on: Oct. 29, 2019

Description: Regulatory expert Alan Minsk shares best practices for adhering to the recent Instruction for Use (IFU) guidance and expected implications on new drug applications and biologics license applications. He discusses:

• How the current content and format for IFUs will need to be modified;
• Examples of sample labeling that cover all elements of an IFU—from dosage and usage to storage and disposal;
• Examples of the kind of recommendations the FDA makes in terms of design and layout; and
• Practical considerations on patient labeling.

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Speaker: Alan Minsk, partner, Arnall Golden Gregory LLP

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