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GeneEd Releases New Regulatory and Compliance (GxP)
E-Learning Library
GeneEd develops unique Regulatory & Compliance e-Learning library
For the Biopharmaceutical Industry using its award-winning technology
SAN FRANCISCO, CA, June 9, 2003—
GeneEd, Inc., the leading provider of advanced e-Learning solutions
for the life science industry, today announced that it has created
new e-Learning content focused on Regulatory and Compliance practices
and procedures. These lessons have been added to GeneEd’s
unique content library composed of several thousand learning objects,
each of which are 2-7 minute-long animations presenting a single
concept. These objects can be rapidly assembled into customized
courses on demand using GeneEd’s Repurposing Engine TM and
presented to the student via the GeneEd Viewing Engine TM Interface.
This flexibility allows custom-specific courseware to be provided
in a cost effective and timely manner.
The new content incorporates the latest “best practices”
in the following areas:
· Introduction to Life Science Regulatory and Compliance
Issues (Intro to GxP)
· Good Manufacturing Practices (GMP)
· Good Laboratory Practices (GLP)
· Good Clinical Practices (GCP)
· Serious Adverse Events (SAE)
· Electronic Records and Signatures (21 CFR Part 11)
Pharmaceutical, biotechnology, and medical device companies are
required to meet FDA GxP requirements prior to marketing a product.
GeneEd’s unique regulatory and compliance e-Learning library
covers in detail the FDA and ICH, regulations for ensuring the integrity
and quality of every stage in drug and device development. In addition,
employees involved in regulatory and compliance issues must be certified
as having completed training in the appropriate regulations and
guidance.
“The GxP content library addresses a growing need within
the life science industry to train and educate employees in rules
and regulations that carry hefty consequences when not adhered to,”
said Dr. Sunil Maulik, GeneEd’s Co-Founder and CEO. “While
numerous organizations provide regulatory and compliance training,
none have been effective at creating dynamic compelling learning.
We are changing that today by use of our proprietary and effective
Repurposing™ and Viewing™ engines. These patented, proprietary
technologies allow the ever-changing regulatory and compliance issues
to be dynamically updated and delivered via e-Learning.”
Regulatory and compliance guidelines now involve nearly every aspect
of drug discovery and development, including manufacturing, clinical
trials, marketing, sales, and distribution. This newest addition
to GeneEd’s growing e-Learning library not only exemplifies
it’s scientific and industry expertise, it also helps fulfill
the company’s stated goal of being the only successful enterprise-wide
e-Learning solutions provider to the life science and healthcare
industries.
All GeneEd catalog and custom courseware are Continuing Medical
Education (CME) Category One accredited and approved. GeneEd curricula
also allow rapid technical integration into any organization's Learning
Management System (LMS). All GeneEd e-Learning courses and learning
objects are SCORM 1.2 compliant, and have been successfully integrated
with 21CFR Part 11-compliant LMS applications.
About GeneEd
GeneEd, Inc. was founded in 1997 to provide life science and healthcare
e-Learning solutions for the pharmaceutical, biotechnology, instrument
and medical device, and hospital/HMO industries. GeneEd's life science
industry customers include AstraZeneca, Accenture, Amgen, Amersham
Biosciences, Pfizer, Johnson & Johnson, Celera, Bio-Rad, IBM
Life Sciences, and Genentech, amongst many others. (http://www.geneed.com/customers.html)
GeneEd utilizes the best life science content, combined with advanced
e-Learning development technology, to rapidly create basic and advanced
curricula in the areas of genomics, therapeutic area training (for
clinical research, product development, and sales and marketing
teams), computer assisted drug design, drug discovery and development,
pharmacogenomics and clinical genomics, bioinformatics and microarray
informatics, and therapeutic and diagnostic products. GeneEd, Inc.
is a privately held company headquartered in San Francisco, California.
Visit http://www.GeneEd.com for additional information about GeneEd
and its courseware.
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