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DTSTAMP:20260417T013716Z
SUMMARY:Webinar on Quality Agreements and Annual Inspections
DESCRIPTION:Overview: Make sure our current thinking on defining, esta
 blishing, and documenting the responsibilities of each party (or all p
 arties) involved in the contract manufacturing of drugs subject to Cur
 rent Good Manufacturing Practice (CGMP) as well as vendors supplying p
 roduct specific raw materials unique to this product.\nIn particular, 
 we will discuss how parties involved in purchasing critical raw materi
 als that can generate patient risk and when the contract manufacturing
  of drugs have to utilize Quality Agreements to assure drug quality, s
 afety, and efficacy. Quality Agreements are required for the commercia
 l manufacturing of Active Pharmaceutical Ingredients (APIs or drug sub
 stances, or their intermediates), as well as finished drug products fr
 om a CMO, combination products, and biological drug products. The inte
 nt of this webinar is to ensure we gain the proper perspective of the 
 terms related with “manufacturing” which includes processing, pack
 ing, holding, labeling operations, testing, and operations of the Qual
 ity Unit.\nWhy should you Attend:\nTo avoid 483's, Warning Letters and
  a Consent Decree.\nAreas Covered in the Session:\nWhat is a Quality A
 greement???Defining the Who and What of Contract Manufacturing includi
 ng vendor suppliers for specific raw materialsEstablishing responsibil
 ities of critical vendors and CMOsContract Manufacturing and Quality M
 anagementDocumenting contract manufacturing arrangements using the Qua
 lity Agreement. or agreements.Elements of a Quality AgreementObjective
  Evidence to demonstrate ComplianceContract Laboratories are Contracte
 d Facilities Subject to CGMP Requirements\nWho Will Benefit:\nQuality 
 Control and Quality AssuranceSenior ManagementRegulatory AffairsCMO Le
 adershipQuality Systems PersonnelR&D and Engineering StaffNew Product 
 DevelopmentCompliance ManagersManufacturing EngineersConsultants\nSpea
 ker Profile:\nJerry Dalfors has extensive (40 years) of business admin
 istration, consultative, technical and managerial experience in the de
 velopment and manufacture of highly regulated biopharmaceutical produc
 ts including injectables, biologics, medical devices and oral dosages.
 \nHe has held permanent employee, temporary employee and company repre
 sentative management positions with a multitude of the major pharmaceu
 tical and biotechnology companies in the US. He has worked with or ass
 isted more than two dozen companies with the establishment of controll
 ed document/quality systems, FDA briefing and submittal documents, pro
 ject management of several multimillion dollar projects including desi
 gn, start-up and validation to assure fast track FDA approval by maint
 aining strict regulatory compliance during all phases of engineering, 
 construction, commissioning and validation, and has written numerous s
 ubmission documents for product.\nContact Detail:\nNetZealous - Compli
 ance4All,161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA.Phon
 e: +1-800-447-9407Email: support@compliance4All.comhttp://www.complian
 ce4all.com/Event Link : http://bit.ly/1Ms42fv\n\nFor more information
  visit https://medtechiq.ning.com/events/webinar-on-quality-agreements
 -and-annual-inspections
DTSTART;TZID=America/New_York:20151202T100000
DTEND;TZID=America/New_York:20151202T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:
URL:
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012284?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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