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QA Checklists for better FDA Audits and Submissions

  • 09 Jul 2020
  • 11:00 AM

Registration

  • Non-Savvy member need to register for this webinar.

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How ready is your team for QA audits?  Have you consistency followed good programming, QC and QA SOPs?  Do you perform internal informal QA audits on a regular basis to 'better manage' quality of SDTMS, ADaMs, Tables, Lists and Graphs?  Or do you wait towards the end of of final qc to start the qa process?  Do you have checklists for each level of development, transformation and reporting?  Instead of 'being surprised', do you want to have more control throughout the process and have time towards the end to focus on unexpected new or more complex tasks?

Attend this unique webinar to explore 10 checklists for better FDA Audits and Submissions.  We will take an overview of the types of checks without going into details.  Smarter organizations have taken the time to identify and or create macros to apply checklists on these topics - Raw Data to SDTMs to ADaMs Transformation Checklist, Clinical Study and CDISC Compliance, Pinnacle 21 Define.XML Issues, 4. Pinnacle 21 Enterprise SDTM / ADaM Reviewer Guide, Pinnacle 21 Define Specefication to Define XML, Automation Rules and Ladder, Final SAS Programs and FDA Validation Rules, FDA Audit-Ready Checklist, and CRF, SDTM, ADaM, TLF and Submission QC/QA Macros.

SAS Savvy Premium/University Members attend for free but still need to register. Non SAS Savvy Premium Members must pay $65. It's not too late to upgrade today to attend for free.   

Computer and phone connections are required. Webinar will be recorded for on-demand viewing.

This training webinar is sponsored by TalentMine.  



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