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DTSTART:19700308T020000
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UID:2140535:Event:425819
DTSTAMP:20260420T120913Z
SUMMARY:Quality and GMP Compliance for Virtual Companies (Pharmaceutic
 al and Biologics Industries)
DESCRIPTION:Today, many companies operate on an outsourcing model. Thi
 s is very common for companies who are evolving from being mainly deve
 lopment-focused to a point where they are entering latter stages of Ph
 ase 2 or Phase 3 clinical trials, and plan to have a product ready for
  market approval in the coming months. Most such companies are small, 
 and may not have deep expertise in QA and GMP compliance, relying on t
 heir partners to cover those areas. Companies who outsource the majori
 ty of operations through the use of Contract Manufacturing Organizatio
 ns (CMOs), Contract Research Organizations (CROs) and Contract Laborat
 ories, however, remain responsible for the quality and compliance stat
 us of the products they send to the clinic or to the marketplace.\nIn 
 this two day workshop conference you will learn the requirements and e
 xpectations of major health care regulators that are applicable to \"v
 irtual\" companies. You will learn how to diagnose your company's need
 s based on which GMP and GCP-governed operations you retain and which 
 you outsource; what the current expectations and best industry practic
 es are for selecting, qualifying and monitoring your contractors to en
 sure they are meeting your requirements; and how to build a quality sy
 stem framework that is not excessive for your current needs, but has t
 he structure and integration to \"grow with you\" as the scope your op
 erations change in the coming months and years.\nYou will also learn b
 est practices for managing a regulatory inspection, with emphasis on F
 DA, EMA and Health Canada, but applicable to most other major agencies
  as well.\nLearning Objectives:\nParticipants in this seminar will:\n\
 nUnderstand the GMP and GCP requirements all virtual companies must me
 et regardless of the extent of their outsourcing operations\nUnderstan
 d how to select, qualify and monitor CMOs, CROs and Contract Laborator
 ies\nLearn the elements to include in a quality agreement (also known 
 as a technical agreement)\nLearn how to determine which GMP or GCP req
 uirements apply to you, depending on the things you do internally and 
 those you outsource\nUnderstand your obligations under the law for pro
 ducts you release to the clinic or the marketplace\nAppreciate the imp
 ortance of maintaining data integrity\nLearn how to effectively manage
  a health regulatory inspection:\nInspection logistics\nResponding eff
 ectively to document requests and questions from inspectors\nManaging 
 the inspection exit discussion\nHow to write an effective response to 
 inspection observations\nHow to find applicable inspection references 
 and procedures of the FDA, EMA and Health Canada\n\n\n\nWho will Benef
 it:\nThis course is designed for those charged with managing Quality A
 ssurance and Regulatory Affairs for companies in the development or co
 mmercial phase of growth who either release investigational drugs to c
 linical trial sites or send commercial products to the market, but rel
 y to a great extent on the use of Contract Manufacturers and/or Contra
 ct Laboratories. The following personnel will benefit from the course:
 \n\nSenior quality managers in manufacturing QA/GMP or clinical qualit
 y areas\nQuality professionals\nRegulatory professionals\nClinical Ope
 rations\nCompliance professionals\nQuality auditors – GMP and GCP\nD
 ocument control specialists\n\n\n\n\n\n\nFor more information visit ht
 tps://medtechiq.ning.com/events/quality-and-gmp-compliance-for-virtual
 -companies-pharmaceutical
DTSTART;TZID=America/New_York:20201210T110000
DTEND;TZID=America/New_York:20201211T170000
CATEGORIES:pharmaceutical
LOCATION:online
WEBSITE:https://www.complianceonline.com/fda-ema-inspection-gmp-gcp-qa
 -for-virtual-companies-seminar-training-80445SEM-prdsm?channel=MedTech
 %20I.Q
URL:https://www.complianceonline.com/fda-ema-inspection-gmp-gcp-qa-for
 -virtual-companies-seminar-training-80445SEM-prdsm?channel=MedTech%20I
 .Q
CONTACT:8887172436
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/8232909081?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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