BEGIN:VCALENDAR
PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN
VERSION:2.0
BEGIN:VEVENT
DESCRIPTION:This program combines general considerations for Good Manufact
 uring Practice (GMP) compliance management with the principles of phase-a
 ppropriate GMP considerations\, with an emphasis on needs of virtual comp
 anies. (“Virtual companies” are those who outsource GMP operations to Con
 tract Manufacturing Organizations (CMOs) and Contract Analytical Laborato
 ries.)\n\nVirtual companies typically do not conduct “hands on” manufactu
 ring\, but do perform tasks which are governed by GMP\, for example\, dis
 positioning final product\, managing the supply chain\, investigating com
 plaints\, and providing training to staff in GMP compliance concepts. Suc
 h companies often struggle to decide how to structure their quality manag
 ement system\, which procedures they need or do not need\, and how to bes
 t manage vendor relationships. In addition\, the application of GMP requi
 rements to the manufacture of investigational products requires exercise 
 of judgement over the life cycle from early phase (Phase 1) to peri-appro
 val (late Phase 3). Understanding what is required by FDA and other regul
 atory agencies is important to assure timely approval\, since GMP complia
 nce issues can result in approval delays.\n\nIn this two half-day worksho
 p conference you will learn how GMP applies directly to virtual company o
 perations\, how to best structure a quality management system in a virtua
 l company\, and a method to decide which procedures are necessary at what
  points in time. You will also learn best practices for quality agreement
 s and vendor management. In addition\, you will learn the current guidanc
 e from FDA for application of GMP to the manufacture of Phase 1\, 2 and 3
  clinical trial materials. Though FDA requirements are the primary emphas
 is\, some discussion of EMA (European) requirements and other venues will
  also be included.\n\nLearning Objectives:\nUpon completing this course p
 articipants should:\n\n\nUnderstand the fundamentals of GMP for the Unite
 d States\nUnderstand how to determine what GMP-governed operations you ar
 e performing internally versus what you are outsourcing\nUnderstand a met
 hod to structure your quality management system and decide which procedur
 es you need now versus which ones can wait\nUnderstand best practices for
  vendor management\nLearn how to apply GMP concepts to Phase 1\, 2 and 3 
 investigational drugs\nLearn the differences between an FDA GMP inspectio
 n\, a Pre-Approval Inspection and a Pre-License Inspection and where to o
 btain guidance for each\nUnderstand basic principles of FDA inspection au
 thority\, what to expect if FDA inspects your virtual firm\, and how to m
 anage the presence of FDA personnel on site\n\nWho will Benefit:\nThis co
 urse is designed for persons responsible for GMP compliance management fo
 llowing a virtual model\, both pre- and post-market. Though designed with
  small company needs in mind\, the principles are also useful to those in
  larger companies who manage CMOs\, particularly those manufacturing inve
 stigational drug API and finished products:\n\n\nSenior quality managers\
 nQuality professionals\nRegulatory professionals\nCompliance professional
 s\nProduction supervisors\nManufacturing engineers\nProduction engineers\
 nQuality engineers\nQuality auditors\n
DTEND:20260304T160000
DTSTAMP:20260512T232623Z
DTSTART:20260303T090000
LOCATION:\,
SEQUENCE:0
SUMMARY:This program combines general considerations for Good Manufacturin
 g Practice (GMP) compliance management with the principles of phase-appro
 priate G...
UID:50bd3edb-fdb0-444d-b668-a94b78047a25
END:VEVENT
END:VCALENDAR