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DTSTAMP:20260525T130343Z
SUMMARY:Webinar On \"GMPs for Active Pharmaceutical Ingredients\"
DESCRIPTION:\nDescription :\nIn this webinar we will discuss the regul
 atory expectations that apply to the production and control of active 
 pharmaceutical ingredients. The discussion will start with the introdu
 ction of ICH Q7, the internationally accepted GMP for APIs, and discus
 s how this is supplemented by contemporary guidance such as ICH Q10, t
 he Pharmaceutical Quality System, ICH Q8, Pharmaceutical Development, 
 ICH Q9 Quality Risk Management and ICH Q11, Development and Manufactur
 e of Drug Substances. The impact of new FDA guidance on Process Valida
 tion and Quality Metrics will also be considered.Why you should attend
  :\nThe objective of this webinar is to provide a contemporary quality
  system approach to the production and control of active pharmaceutica
 l ingredients. Although ICH 7, Good Manufacturing Practice Guidance fo
 r Active Pharmaceutical Ingredients is only 15 years old, the pharmace
 utical industry has gone through a significant transition to a quality
  system approach to development, compliance, production, and control. 
 Compliance activities that include these contemporary concepts must be
  practiced in a compliant organization.\n\n\n\n\nAreas Covered in the 
 Session :\nThe following areas will be included:\n\nDrug GMPs\nICH Q7\
 nICH Q8\nICH Q9\nICH Q10\nICH Q11\nFDA Process Validation guidance\nDa
 ta Integrity\nQuality Metrics\n\n\n\n\n\nWho Will Benefit:\n\nIn the A
 PI manufacturer\nSenior management\nSite managers\nMaterials\nProducti
 on\nQuality Control\nQuality Assurance\nReviewer\nAuditor\n\n\n\n\nIn 
 the Drug Product  Manufacturer\nPurchasing agents\nQuality Assurance\
 nQuality Control\nQuality auditor\n\n\n\n\n\n\n\nAbout Speaker:\nJohn 
 G. (Jerry) Lanese is an independent consultant with a focus on Quality
  Systems and the components of an effective Quality System. He receive
 d a BA and MS from Middlebury College and a Ph.D. in Analytical Chemis
 try from the University of Michigan and began his career teaching Anal
 ytical Chemistry in a small liberal arts college. Dr. Lanese moved fro
 m the academic environment to the pharmaceutical industry where he has
  managed Analytical Research, Quality Control and Quality Assurance fu
 nctions.\n\n\n\n\n\n\nFor more information visit https://medtechiq.nin
 g.com/events/webinar-on-gmps-for-active-pharmaceutical-ingredients
DTSTART;TZID=America/New_York:20180221T130000
DTEND;TZID=America/New_York:20180221T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:http://bit.ly/2BTysHQ
URL:http://bit.ly/2BTysHQ
CONTACT:1-844-216-5230
ORGANIZER;CN="Sam Miller":https://medtechiq.ning.com/profile/SamMiller
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017510?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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