A project manager at a pharmaceutical company is leading a project in the development of a new drug. The project is under strict health, safety, and regulatory compliances. Midway through the project, a new regulation is introduced that could impact the composition of the drug and necessitates an immediate compliance review. What should be the initial step taken to address this new compliance requirement?
Continue with current processes and discuss the new regulation in the next scheduled project review meeting.
Re-assess the project's compliance to the new regulation and identify any areas of noncompliance.
Revise the project schedule to accommodate potential delays
Immediately initiate new training for the project team on the new regulation.
The correct approach to addressing a new compliance requirement, particularly in industries like pharmaceuticals where regulatory demands can have significant project implications, begins with a thorough assessment of the new regulation. This ensures that any consequential changes in project scope or processes are clearly understood before any actions are taken. Identifying areas of noncompliance as soon as the regulation changes aids in efficient and relevant adjustments in project direction. Initiating new training without such an assessment risks implementing incorrect or incomplete changes that may not fully address the new requirements or might even lead to additional compliance breaches.
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