Recorded on: June 24, 2019

Description: Technical expert, author and teacher Jim Polarine shares best practices to stay compliant and get up-to-speed on the latest in risk-based cleaning regulations. He discusses:

• Cleaning and disinfection based on Annex 1 (Draft 2019) and sections of PDA Technical Report No. 70;
• Disinfection rotation;
• Rinsing and residues; and
• Frequencies.

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Speaker: Jim Polarine, Senior Technical Service Manager, STERIS

Recorded on: June 13, 2019

Description: Computer system validation expert David Harrison shares best practices and available options for validating spreadsheets. He discusses:

• FDA examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820;
• How to determine spreadsheet validation gaps the FDA targets;
• How to choose an approach for efficient and repeatable validation that fits into your traditional QA and validation processes; and
• How to plan, manage and resource an effective project.

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Speaker: David Harrison, Principal Consultant, CSV Compliance Ltd.

Recorded on: June 11, 2019

Description: Clinical trial solutions expert Kelly Smith shares best practices for how pharma and biotech companies can best take advantage of key performance indicators. She discusses:

• How to improve business development chances by illustrating turnaround times and other metrics when communicating and selling services to potential clients;
• How to develop better feasibility by quickly and easily finding turnaround times, win rates, loss/not selected rates and potential revenue per patient;
• How to accelerate start-up activity by using KPIs to set goals and measure progress/performance against those goals; and
• Choose improved protocols to set attainable enrollment goals and track financials.

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Speaker: Kelly Smith, Senior Solutions Consultant, Bio-Optronics

Recorded on: June 11, 2019

Description: Business strategist and training experts John Constantine and Kent Malmros Systems share best practices for managing multiple training platforms and complex training requirements. They discuss:

• Delivering compliance-based applications with greater efficiency;
• Supporting blended roles and enabling a more succinct learner experience;
• Ensuring compliant training records and reports are in one place; and
• Providing traceability of the development and delivery lifecycle for all training materials.

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Speakers: John Constantine, Senior Vice President of Talent Solutions, Orchestrall, and Kent Malmros, Senior Director of Vault Training at Veeva Systems

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