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Tuesday, April 10 • 3:30pm - 5:00pm
Session I - GCP/PV Track

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I-1   The Trials and Tribulations of Getting Multiple Laboratories at Multiple Sites to Work as One Cohesive Unit 

If you’re going to bring multiple laboratories of different types and in different locations with different areas of expertise and different quality systems and merge them all into one big happy family to support a high-profile clinical study, you can expect to be faced with significant challenges.  Our lab has done just that and would like to share some of our experiences over the last 3 years of this collaborative effort.  The most significant challenges from the start were (1) developing and implementing a single assay procedure that could be used at any site and obtain consistent and comparable results between sites over an extended period of time, (2) creating and managing a harmonized quality component that would complement but not impede existing  or proprietary systems and procedures, (3) dealing with multiple regulatory applications and expectations based on the nature of the assay, types of laboratories, and requirements of the clinical trial, (4) coordination of specimen handling between sites,  and (5) dealing with a research mentality in a regulated world.  By necessity the various labs had to have some commonalities, which we were able to leverage to our advantage.  But different systems and different perceptions of what needed to be done more often than not created a few speed-bumps – and sometime big potholes - in the road to success.  This presentation will discuss some of the most significant challenges we faced and how we successfully met and resolved them.

Good Clinical Practices

Level of Content:

I-2  How to Make Your FDA Inspection Efficient and Painless

Everybody in the clinical arena; Sponsors, CROs, Clinical Investigators and their staff and all others) fear FDA inspections.  In this presentation I will describe how to make your Regulatory Inspection Efficient and Painless.  This presentation is excellent for all Sponsor Company's, CRO, Auditor's and contract auditros who will be tasked to prepare clinical investigator sites for potential FDA inspections.  During this training, the following topics and points to consider will be covered in depth to help prepare for FDA inspections.
-Describe the FDA Clinical Investigator Inspections
-Describe the inspection process (FDA BIMO Manual)
-FDA Inspection preparation
-Behaviors during the inspection (Do's and Dont's)
-How to respond to FDA questions
-Discuss common inspectional observations and how to respond to them
-Provide FDA metrics from previous year for Clinical Investigator's, IRB's and Sponsor Inspections
-Most common Clinical Investigator deficiencies will be discussed

I developed this presentation and it has been used in 2017 to prepare 14 Clinical Investigator sites in both US and EU as part of my company's FDA Readiness Training Preparation.  This has been well received at all sites and many positive learning experiences have taken place.  This training provides key tips on how to be fully prepared to handle FDA inspections.  With a little training and alot of preparation, most clinical sites can be fully prepared to face the FDA when they visit .  

Good Clinical Practices

Level of Content:

avatar for Pamela Barry

Pamela Barry

Associate Director, Quality GCP, Acorda Therapeutics
Pam has been an active member of SQA since the nearly 90’s and was a founding member in developing the GCP section at SQA.She is the Associate Director of Quality Assurance GCP for Acorda Therapeutics in Ardsley, NY and has been in various roles within QA her entire career of 35... Read More →

Patty Runge

Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research
Patty Runge has been active in the Quality Assurance arena for more years than she would like to admit, starting at Covance (when it was still Hazleton Laboratories), Experimental Pathology Laboratories and EPL Archives, Human Genome Sciences, and currently as QA Manager at the Molecular... Read More →

Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 7&8