Level 3 Course on Radiopharmacy GMP - eanm.org · Facilitators: Jacek Koziorowski Marianne Patt...
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Transcript of Level 3 Course on Radiopharmacy GMP - eanm.org · Facilitators: Jacek Koziorowski Marianne Patt...
Facilitators: JacekKoziorowski
MariannePattPetraKolencPeitlSergioTodde
09:30-09:50 IntroductionoftheSpeakerandtheParticipants09:50-10:20 EvaluationQuiz/AssessmentofStartingKnowledge10:20-11:00 IntroductiontoGMP(NG)-PartI
11:20-12:00 IntroductiontoGMP(NG)-PartII12:00-12:10 Q&A
13:10-13:50 URS(PL)
13:50-14:10 HandsonTraining:WritinganURS
14:10-14:50 Discussion/Interactivesession
15:10-16:10 ClinicalTrials+IMPD(MP)
16:10-16:30 Discussion/Interactivesession
SessionII-IntroductionPart2
Level3CourseonRadiopharmacyGMP
SessionI-IntroductionPart1
11:00-11:20CoffeeBreak
Day1
Thursday,9November2017
16:30EndofDay1
12:10-13:10LunchBreak
SessionIV
SessionIII
14:50-15:10CoffeeBreak
09:00-09:40 Validation(ST)
09:40-10:00 HandsonTraining
10:00-10:20 Discussion/InteractiveSession
10:40-11:00 OOSandCAPA(JK)
11:00-11:15 HandsonTraining
11:15-11:30 Discussion/InteractiveSession
11:30-12:10 FacilityPlanning(incl.Monitoring,ProductionandQCEquipment(ST))
12:10-12:30 Discussion/InteractiveSession
13:30-14:10 QualityRiskManagement(incl.ChangeControl/Mgmt&RiskAssessment)(JK)
14:10-14:30 HandsonTraining
14:30-15:30 PanelDiscussion15:30-15:40 StretchyourLegs15:40-16:10 Evaluation/TestofGainedKnowledge16:10-16:40 DebriefingoftheCourse/DiscussiononLastOpenQuestions
10:20-10:40CoffeeBreak
SessionVI
12:30-13:30LunchBreak
SessionVI
Day2
16:40EndofDay2
Friday,10November2017SessionV