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DTSTART:19700308T020000
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DTSTAMP:20260828T234547Z
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.\n\n\n\n\n\nAreas Cov
 ered in the Session :\nThe following areas will be included:\n\nDrug G
 MPs\nICH Q7\nICH Q8\nICH Q9\nICH Q10\nICH Q11\nFDA Process Validation 
 guidance\nData Integrity\nQuality Metrics\n\n\n\n\n\n\nWho Will Benefi
 t:\n\nIn the API manufacturer\nSenior management\nSite managers\nMater
 ials\nProduction\nQuality Control\nQuality Assurance\nReviewer\nAudito
 r\n\n\n\n\nIn the Drug Product  Manufacturer\nPurchasing agents\nQual
 ity Assurance\nQuality Control\nQuality auditor\n\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 Sy
 stem. He received a BA and MS from Middlebury College and a Ph.D. in A
 nalytical Chemistry from the University of Michigan and began his care
 er teaching Analytical Chemistry in a small liberal arts college. Dr. 
 Lanese moved from the academic environment to the pharmaceutical indus
 try where he has managed Analytical Research, Quality Control and Qual
 ity Assurance functions.  In 1994 Dr. Lanese formed his own company, T
 he Lanese Group, and since that time he has been a consultant in the a
 rea of quality system and cGMP compliance and has audited and consulte
 d with small and large medical device and pharmaceutical companies, in
 cluding companies under FDA Consent Decree, API and excipient manufact
 urers, electronic firms and other manufacturing organizations.\n\n\n\n
 \n\n\nFor more information visit https://medtechiq.ning.com/events/web
 inar-on-gmps-for-active-pharmaceutical-ingredients-1
DTSTART;TZID=America/New_York:20181023T130000
DTEND;TZID=America/New_York:20181023T143000
CATEGORIES:online, "/", webinar
LOCATION:Online
WEBSITE:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=PH000
 78
URL:https://www.compliancetrainingpanel.com/Webinar/Topic?WB=PH00078
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/2562019568?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Sam Mill
 er":https://medtechiq.ning.com/profile/SamMiller
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