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