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Wednesday, April 11 • 8:30am - 10:00am
Session L - GMP Track

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L-1  Achieving a “Culture of Quality” in a GMP CRO/CMO environment

A Quality Management System (QMS) incorporates the systems and processes by which regulated activities are performed. Training provides the skills and capabilities to deliver against QMS requirements. However, without the correct attitudes and behaviours instilled in those who operate within the QMS, it is unlikely that any organisation will deliver against its regulatory obligations and customer expectations.
Implementation of a “Quality Culture” in a highly regulated industry is challenging, but also very rewarding.  Drawing on our own experiences, this session will discuss the benefits of implementing the right “ Quality Culture”, along with the behaviors and actions critical to maximizing the potential rewards.

Good Manufacturing Practices

Level of Content:

L-2  Failure to Investigate

To this day, "failure to thoroughly investigate," is still cited by the FDA in warning letters making the need for thorough investigations crucial for cGMP facilities.  In 2016 this finding ranked number 3 on the FDA”s list of drug inspectional observations summary.  This session is intended to review the FDA's OOS Guidance Document and possible things to consider when conducting an investigation to ensure failures are thoroughly investigated.  

Good Manufacturing Practices

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L-3  Aligning Security with Partner Engagement Models for Greater Quality Oversight 

With outsourcing of critical functions, maintaining quality oversight is critical. Audits alone are no longer sufficient and many companies are demanding ongoing data and content from partners that include stability tests, batch records, deviation and investigation reports, and CAPAs.
Companies are also sending official procedures and documents to partners – in the form of contractor manuals – that must stay current. Updates received by partners need to be acknowledged and often require additional information such as implementation date. Current methods of using email, file shares, and phone calls do provide an audit trail of who sent, reviewed, or accepted the information – creating compliance risks and eroding data integrity.
Incorporating partners into processes with modern applications provides a scalable, seamless experience for both parties that can be tracked and easily monitored. With a wide range of partner engagement models, security plays a fundamental role in the technology. Learn how pharmaceutical companies are collaborating with contract organizations and how security is setup to ensure information is securely shared between both parties. We will also discuss:
-Different partnership models, challenges, and benefits
Security requirements for each model and how technology can meet those needs
-How to leverage security and controlled workflows to reinforce roles and responsibilities and prevent partners from accessing each other’s information
-How to operationalize lot release process, stability test review, technology transfer, and contractor manuals
-Sample workflows with contract manufacturing organizations (CMOs) and test labs (CTLs)
-How security will evolve in the next 3-5 years to meet outsourcing demands

Good Manufacturing Practices

Level of Content:

avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →

avatar for Reed Bailey

Reed Bailey

Covance Laboratories
As a quality leader for Covance,Sr. GMP QA Manager for North America Covance,  I manage the GMP Quality Assurance team that supports analytical testing for clinical and commerical batch release as well as the GMP batch release for early Phase clinical studies.  Prior to my role... Read More →

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →
avatar for Sandeep Chopra

Sandeep Chopra

VP Product Management, Veeva Systems
Sandeep has over ten years of experience developing security products and providing security services. At Veeva, he was responsible for Vault platform security before becoming VP of product management for the Vault Quality Suite. Sandeep previously led product teams at Deloitte, MobileIron... Read More →

Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 1&2