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DESCRIPTION:In this two day workshop conference you will learn the require
 ments and expectations of major health care regulators that are applicabl
 e to "virtual" companies. You will learn how to diagnose your company's n
 eeds based on which GMP and GCP-governed operations you retain and which 
 you outsource\; what the current expectations and best industry practices
  are for selecting\, qualifying and monitoring your contractors to ensure
  they are meeting your requirements\; and how to build a quality system f
 ramework that is not excessive for your current needs\, but has the struc
 ture and integration to "grow with you" as the scope your operations chan
 ge in the coming months and years.\n\nLearning Objectives:\nParticipants 
 in this seminar will:\n\n\nUnderstand the GMP and GCP requirements all vi
 rtual companies must meet regardless of the extent of their outsourcing o
 perations\nUnderstand how to select\, qualify and monitor CMOs\, CROs and
  Contract Laboratories\nLearn the elements to include in a quality agreem
 ent (also known as a technical agreement)\nLearn how to determine which G
 MP or GCP requirements apply to you\, depending on the things you do inte
 rnally and those you outsource\nUnderstand your obligations under the law
  for products you release to the clinic or the marketplace\nAppreciate th
 e importance of maintaining data integrity\nLearn how to effectively mana
 ge a health regulatory inspection:\n\nInspection logistics\nResponding ef
 fectively to document requests and questions from inspectors\nManaging th
 e inspection exit discussion\nHow to write an effective response to inspe
 ction observations\nHow to find applicable inspection references and proc
 edures of the FDA\, EMA and Health Canada\n\n\nWho will Benefit:\nThis co
 urse is designed for those charged with managing Quality Assurance and Re
 gulatory Affairs for companies in the development or commercial phase of 
 growth who either release investigational drugs to clinical trial sites o
 r send commercial products to the market\, but rely to a great extent on 
 the use of Contract Manufacturers and/or Contract Laboratories. The follo
 wing personnel will benefit from the course:\n\n\nSenior quality managers
  in manufacturing QA/GMP or clinical quality areas\nQuality professionals
 \nRegulatory professionals\nClinical Operations\nCompliance professionals
 \nQuality auditors – GMP and GCP\nDocument control specialists\n
DTEND:20260219T160000
DTSTAMP:20260514T155050Z
DTSTART:20260218T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:In this two day workshop conference you will learn the requirement
 s and expectations of major health care regulators that are applicable to
  "virtua...
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