Medpace will once again be active participants in the Society of Quality Assurance’s (SQA) Annual Meeting and Quality College, 28 April – 3 May, 2019 in Atlanta, GA.
“The SQA Annual Meeting is an important platform for bringing together Industry QA Professionals and Regulators to train and educate through the SQA Quality College, to engage on current topics in GLP, GMP and GCP, and to collaborate on and debate best practice for the QA professional supporting research and development of drugs, biologics and devices,” commented Eric Humes, Executive Director, Quality Assurance at Medpace, and SQA Board of Directors. “This year, I am personally honored to be leading a workshop on navigating the differences of EMA/FDA GCP inspection preparation and management. Dr. Cynthia Kleppinger, Sr. Medical Officer, Division of Clinical Compliance for the FDA will be participating as a panelist in the workshop; it promises to be highly informative and insightful.”
Medpace will be participating in three sessions in the SQA program that highlight industry challenges, innovation and best practices.
1. ) Session J: EMA/FDA GCP Inspection Preparation and Management: Navigating Inspection Process Differences, Tuesday, April 30th 3:30 – 5:00pm
Workshop leader and facilitator: Eric Humes, Executive Director, Quality Assurance, Medpace
The workshop is comprised of three (3) breakout sessions covering pre-inspection preparation, inspection management and responding to observations. Dr. Cynthia Kleppinger, Sr. Medical Officer, Division of Clinical Compliance for the FDA is participating in the workshop.
Abstract: A key role of the GCP QA professional today is managing and supporting inspection readiness activities, leading interactions with Inspectors in the front room, coordinating back room activity, and when applicable, facilitating response to observation. The lack of harmonization between the major inspectorates presents challenges to Sponsor and CRO QA coordinating inspection readiness, preparation and management for global drug/biologic development programs. In this interactive workshop, we will focus on the FDA and EMA GCP Inspection processes to inform attendees of the differences in preparing for and managing inspections by examining best practice through real-world examples and examination of FDA and EMA expectations during an inspection. Attendees will participate in roundtable discussions throughout the workshop to further examine the inspection readiness and preparation process, the management of the inspection and managing formal observations.
2.) Session G-3: Strategy for Quality Risk Management in Laboratory Settings, Tuesday, April 30th 3:30 – 5:00pm
Presenter (30 minutes): Shon Logue, RQAP-GLP, Associate Director, Quality Assurance, Medpace
Abstract: This presentation will focus on the application of Quality Risk Management (QRM) in establishing a risk-based audit approach in GLP and GCP laboratories. It will examine the similarities and differences which can be applied across laboratories. Topics will include:
- Enabling a better focus in using fact-based decision making through the use of data, metrics, CAPAs, and previous audits or commitments in support of assigning the likely risk for a process;
- Where to begin and understanding the baseline, frequency, and documentation. This will include working with operational staff in determining the probability of occurrence and the severity if the process fails;
- A practical approach on resource management;
- How this higher level approach differs from a project level approach;
- Various documentation aspects, and;
- The re-evaluation or effectiveness of the process in order to continually improve.
3.) Session N-2: Controversies for Clinical Labs, Wednesday, May 1st 8:30 – 10:00am
Presenter (60 minutes): Stacey Lindeman, RQAP-GLP, QA Auditor, Medpace
QA Expectations for Labs Used in Clinical Research
Clinical Lab Quality Assurance professionals get little help or advice in coordinating compliance between multiple and often contradictory requirements for labs conducting clinical research. Participating as a presenter and panelist, Stacey will cover guidance and expectations for documentation for these labs, such as accreditations and reference range requirements as well as inclusion on the 1572. Additional topics to be discussed will be GCP/ GCLP expectations in labs performing secondary and exploratory endpoints, waived testing during clinical trials, and regulation/guidance of Laboratory Developed Tests in clinical research.
Abstract: CLIA sometimes seems to be the forgotten component of GCP, and sponsors often seem to forget that clinical laboratories have to deal with CMS as well as FDA, ICH, and sometimes even state regulations. Clinical Lab QAs get little help or advice in coordinating compliance between multiple and often contradictory requirements. This panel discussion brings together real QA auditors to see how they have met this challenge. Some of the topics for discussion will include GLP vs CLIA in novel testing situations, precedence and application of state vs. federal vs. international requirements, and how bioanalytical guidance is being applied to routine clinical testing. There will be plenty of opportunity for audience participation and comment, so bring your experiences to share!