(1888PressRelease)
August 13, 2008 - Protocol Link, Inc., a leading project management and consulting firm to the FDA-regulated life sciences industry, today announced the addition of a white paper in its publication series. Titled “Demystifying Training Program Requirements in an FDA-Regulated Environment,” it provides knowledge-sharing in establishing compliant training processes to professionals working in the pharmaceutical, biotech, and device industries.
The author succinctly defines and describes the essential elements of training program requirements in an FDA-regulated environment and demystifies the process of setting up a compliant program by providing an overview of vital training topics, a review of the regulatory and global compliance landscape, and highlighting key components required for constructing a sound training program.
“Working in a regulated environment dictates the need for a compliant training program to ensure that regulatory and key business goals are realized in a controlled manner,” said Adriane Johnson, the author. “Setting up a formalized training program that incorporates the essential elements provides assurance that employees are qualified and fully trained in the particular operations that they perform in accordance with the current Good Manufacturing Practice (cGMP) and applicable global regulations,” she added.
Ms. Johnson has more than 10 years of experience in the pharmaceutical industry and has implemented several regulatory compliant training programs. She is a certified Professional in Human Resources (PHR) and holds a Master of Jurisprudence in Business Law from Loyola University Chicago School of Law.
About Protocol Link
With an established client base worldwide, Chicago-based Protocol Link, Inc., is a leading project management and consulting firm dedicated to providing comprehensive regulatory compliance, quality assurance, cGMP documentation, validation, and technology services to FDA-regulated life sciences companies worldwide. Founded in 1996, Protocol Link’s mission is to provide customer-focused services with ethical conduct, mutual trust, and personnel empowerment. Additional information can be obtained by visiting Protocol Link’s Web site at: www.protocollink.com.
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