Recorded on: July 23, 2019

Description: GxP expert David Chesney shares best practices for creating effective new SOPs for electronic document management or improving existing SOPs. He discusses:

• The legal basis of FDA records access authority;
• The types of documents commonly requested during inspections;
• The perils of emails as GxP documentation, and how to avoid them; and
• The impact of the shift to real-time electronic review of documents during inspections.

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Speaker: David Chesney, Principal and General Manager, DL Chesney Consulting, LLC

Recorded on: July 18, 2019

Description: Industry expert Dan O’Leary shares how the latest regulations, standards and FDA guidance documents impact the validation of production processes of medical devices with animal tissue, and the implementation of compliant systems to protect patient and user health. He discusses:

• The elements of the FDA guidance document and how they fit into the U.S. regulatory system;
• The members of the ISO 22442 rule family and how they work together;
• The upcoming changes to the ISO 22442 rule family; and
• The approach to animal tissues in the EU-MDD and EU-MDR, and the factors for implementation.

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

Recorded on: July 17, 2019

Description: Quality systems expert JP Zonnenberg and strategy expert Mike Jovanis share best practices on how to calculate anticipated benefits and savings and build a business case to justify quality transformations. They discuss:

• The framework for developing business cases;
• How to move from a cost to a value structure leveraging Quality 4.0;
• The recommendations on calculating TCO and key considerations; and
• Guidance on navigating complex organizations to get buy-in.

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Speakers: Jan Paul (JP) Zonnenberg, Partner, Pharmaceutical and Life Sciences Companies, PricewaterhouseCoopers; Mike Jovanis, Vice President, Vault Quality, Veeva Systems

Recorded on: July 10, 2019

Description: Technical expert Wayland Rushing shares best practices for understanding and performing appropriate Extractables and Leachables studies. He discusses:

• What they are and the special issues they pose;
• The regulatory requirements involved with ICH Q3D guideline requirements, etc.;
• What to consider when designing a Extractables and Leachables program; and
• The analytical challenges associated with Extractables and Leachables.

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Speaker: Dr. Wayland Rushing, Director of Scientific Affairs, Eurofins

Recorded on: June 26, 2019

Description: Industry expert David B. Russell shares proven ways to ensure that all the funds allowed in CTAs are collected during financial audits. He discusses:

• How to perform financial lookbacks on open studies and those in closeout;
• How to insert language into CTAs to ensure the study sponsor/CRO provides all the necessary documentation associated with payment;
• When to do a financial audit; and
• How best to handle budget amendments.

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Speaker: David B. Russell, CRCP, Director, Site Strategy, PFS Clinical

Recorded on: June 26, 2019

Description: Quality Assurance expert Susan Schniepp shares best practices on the importance of an effective CAPA system, investigational techniques used in CAPA management and how CAPA can be used to drive continuous process improvements. She discusses:

• How to establish meaningful effectiveness checks;
• How to conduct world-class investigation process overviews to help comply with regulatory requirements;
• How to use discovery through closeout for every deviation from CAPA guidelines; and
• How to understand the nuances involved in lab OOS investigations.

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Speaker: Susan Schniepp, Distinguished Fellow, Regulatory Compliance Associates

Recorded on: June 25, 2019

Description: Quality Management expert James “Gunny” Shore shares best practices on evaluating your current QMS, identifying the areas that need to be simplified and making your QMS easier to follow. He discusses:

• How to use the proper tools and methodology to evaluate your QMS;
• How to assemble a gap assessment and improvement plan;
• How to develop a comprehensive roadmap to implement an efficienty QMS through lean manufacturing processes; and
• How to change employees’ behavior to increase productivity.

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Speaker: James “Gunny” Shore, Chief Quality Officer, Quality Lean Solutions

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