CDISC Mapping 1: Specifications and FDA Requirements
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , Documentation and IT , HEALTHCARE , Hospital Management , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management

CDISC Mapping 2: ODM, MindMaps and References
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , All FDA Regulated Industry , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , All FDA Regulated Industry , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , All FDA Regulated Industry , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , All FDA Regulated Industry , Documentation and IT , Quality and Safety , QMS, ISO 13485, CAPA , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Life sciences QA/QC , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , QA/QC

CDISC Mapping Webinar Series: Comprehensive Training Package (5 Courses)
Category: Drugs and Chemicals (Pharma)

CDISC Mapping Webinar Series: Comprehensive Training Package (5 Courses)
Category: Drugs and Chemicals (Pharma)

Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables
Category: Drugs and Chemicals (Pharma) , Clinical Research , All FDA Regulated Industry , FDA 21 CFR Part 11 , Documentation and IT , GCP & Other Best Practices , Trial Design and Management , Risk Management & Controls , All FDA Regulated Functions , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment
Category: Drugs and Chemicals (Pharma) , Medical Devices , Clinical Research , Biotechnology , All FDA Regulated Industry , FDA Audit and Inspection , GXP Pharmaceutical , GXP Medical Devices , FDA 21 CFR Part 11 , Quality and Safety , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Audit & Inspection-Role , All FDA Reg. based Audit , Life sciences QA/QC , Regulations & Guidances , Best Practices & GXPs , Life Sciences , Regulatory Affairs , Documentation and Data Management , Common FDA Regulations , QA/QC

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation
Category: Drugs and Chemicals (Pharma) , Clinical Research , Biotechnology , All FDA Regulated Industry , GXP Pharmaceutical , FDA 21 CFR Part 11 , Documentation and IT , Quality and Safety , GCP & Other Best Practices , Quality & Safety , Drugs Regulations , Clinical Trial Regulations , Biotech Regulations , Documentation and Policy Management , Lifescience process & Procedures , Research & Development , Drug R & D , Regulations & Guidances , Life Sciences , Regulatory Affairs , Documentation and Data Management , Roles and Responsibilities , Common FDA Regulations