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Wednesday, April 11 • 10:30am - 12:00pm
Session S - GCP Track

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S-1   How to select the most appropriate effectiveness check for your corrective action

Once a corrective action has been implemented, it is important to assess the success of the action to prevent reoccurring issues. This is activity is called an effectiveness check. The type of effectiveness check that one selects is depenendent on a number of factors such as complexity of the issue, the frequency of a particular activity occurs in the business, and the ability to measure the impact of the corrective action. In this presentation, different types of effectiveness checks will be discussed with examples along with their appropriateness for different types of corrective actions.

Good Clinical Practices

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S-2  Implementing Real Quality Management in Virtual Companies: How to Master the Challenge

There are companies out there that function without a company office, with employees being internationally dispersed and working remotely. These organizations may consist of a handful of enthusiastic experts in their field that are providing services in a small niche. They function in a different manner than traditional organizations.
When such an organization is a CRO, clients often have doubts about the CRO's ability to comply with project and regulatory requirements, just because they are different and not a mirror of their own company. When asked to assist with the implementation of a Quality Management System for such a CRO, there are numerous aspects to consider to ensure the resulting system serves the CRO, but also convinces their clients and last, but not least, the regulatory authorities.
Can 'Real Quality' be achieved in a 'Virtual Organization'? The presentation will tell the story of the QMS development and implementation, the discussions around it, the challenges encountered (internally as well as with clients) and which solutions worked and which did not. Of course, as always, time was of the essence and the QMS needed to be ready within a couple of weeks. Which questions must be asked and answered, which documents be generated? What is vital to make a virtual organization prepared for client audits and inspections?
QMS are dynamic and of course, the QMS may be further enhanced or radically changed. Be courageous, but be also careful that the organization can digest the changes.

Good Clinical Practices

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S-3 Quality by Design and its Impact on QA

With the advent of risk management and the quality management approach under Good Clinical Practice (GCP), among other new concepts, the principles of Quality by Design (QbD) has converged on the clinical arena and is impacting our daily work as QA professionals.  One area that is continually struggling is the development of an adequate robust product development plan, which among other areas includes protocol and trial development.  If the product development plan is not designed properly up-front, besides adding to errors, loss of productivity and increasing costs in clinical trial conduct, obtaining regulatory clearance/approval to market a given product can become a very difficult and time consuming task. In this age of quality management systems impacting the Clinical arena, more and more QA personnel are reporting they are being asked to step into roles that were not traditionally seen as QA roles.  This session will explore the impact of QbD on the QA role, provide an overview of what it entails, and provide some practical tips on how best to accommodate those requests without compromising QA.

Good Clinical Practices

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Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Leslie Sidor

Leslie Sidor

Senior Director Quality Risk Management, Biogen
Leslie is the Senior Director of Quality Risk Management in R&D Quality, Operations and Performance at Biogen where she is responsible for R&D’s Quality Management System. Prior to joining Biogen, she led the Global Quality Engineering team at Amgen where she was responsible for... Read More →
avatar for Lee Truax-Bellows

Lee Truax-Bellows

President, CRO, NCRA
Lee Truax Bellows, RQAP-GCP, CCRALee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a GCP Quality Auditor, Trainer, and Project Manager. Lee has been involved in regulated research for the past 28 years... Read More →

Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 7&8