● Describe no fewer than three (3) historical events that drove the development of GMPs.
● Identify no fewer than three (3) quality rules to ensure IMP production meets global regulatory standards.
● List three (3) regulatory/quality requirements when shipping temperature controlled IMPs.
● Explain how stability studies generate shelf life dating
● Identify the greatest challenge of the new Clinical Trial Regulation and how it will effect Clinical Supplies.
● List no fewer than two (2) key requirements to developing good IMP SOPs.