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COURSE ID 2970

Basic FDA GLP Training (Good Laboratory Practice Training)

AVAILABLE On-demand
2 Hours

On-Demand

Offering Price
$ 395
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Team Training

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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

ACCREDITATION CEU's - 0.2 IACET RAPS
View Course Outline

No drug makes it into human usage without having first been demonstrated safe in animal models. Good Laboratory Practices (GLPs), which grew out of a lack of quality and scientific integrity in toxicology studies conducted in the 1970s, established FDA’s requirements for the conduct of such nonclinical studies. Bioanalytical analyses for GCP-regulated studies are also expected to adhere to FDA GLP requirements. After more than 40 years in use, revisions to these rules have now been proposed.

This two-hour accredited training session is designed to provide a basic understanding of the FDA GLP Regulations. The history, intent, scope, and requirements of the FDA GLPs and related predicate rules will be provided to achieve that end. Through a basic understanding of the FDA GLP requirements, responsible professionals will be able to successfully manage nonclinical studies and ensure the health and safety of human subjects.

Training on Basic FDA GLP will be provided as a lecture with real life examples and activities.

who should
attend?

LEVEL
Introductory
INTERESTS
Biotechnology / Biopharmaceutical Medical Devices / Diagnostics Pharmaceutical Science & Technology Preclinical / Non-Clinical

Basic FDA GLP training is applicable to the various industries and functions that perform nonclinical laboratory studies under FDA GLP regulations. The Basic FDA GLP Training will be valuable to all individuals working in the animal health, biologics, device, and pharmaceutical industries including:

– New Quality Assurance Auditors

– Quality Assurance Auditors and Managers as refresher training or as GLP skill development

– Quality Assurance Directors as refresher training or as GLP skill development

– Scientists performing GLP-regulated studies

– Laboratory Personnel conducting bioanalytical analyses for GCP-regulated studies

This training is geared toward study management as well as scientific and quality professionals responsible for FDA GLP-regulated activities.

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course instructor

Bonnie M. Pappacena
President, Qualture LLC

Bonnie M. Pappacena’s Courses
Bonnie M. Pappacena is the President, Qualture LLC, a Quality consulting firm committed to building Quality into company culture. Ms. Pappacena has been a Quality professional for over 35 years spanning the animal health, biological, chemical, device, generic, and pharmaceutical industries. She possesses hands-on experience conducting and managing audits in GCP, GLP, GMP (clinical supplies and commercial products), and GVP regulated areas. She is well versed in building quality teams to provide independent, effective quality oversight for regulated areas. Prior to establishing Qualture LLC, Ms. Pappacena was Vice President, Quality at Foamix Pharmaceuticals. She also held the position of Vice President Quality at G&W Laboratories and Acorda Therapeutics. Ms. Pappacena was also employed as a Quality professional while at Schering Plough, Lederle, SmithKline Beecham Animal Health, and Monsanto.

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