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BIOANALYTICA-2017;Recent Trends and Challenges in Bioanalysis

30 June 2017 09:00-18:00, Hyderabad, India


Introduction
      鈻� Key Notes
  • Bioanalytical challenges and due diligence
  • Data integrity and 21 CFR part 11 compliance
  • Challenges in regulatory audits
  • Investigations, root cause analysis & CAPA
  • Micro sampling process and its challenges
  • Method development and challenges
  • Internal audit system and review process
  • Event records and audit trails review
  • Contingency plan for system (Management) failure
  • Qualification of instruments and software platforms
  • Practical issues during analysis and metabolite identification鈥�
  • Scientific real time decision making.
     鈻� Bio statistics :
  •  Bioequivalence statistical analysis in 3 steps
  •  Bioanalytical outlier
  •  Chromatogram sample selection method
     鈻� Medical writing 
  • Scientific report writing (clinical trial document to clinical trial report)

Deadlines

Useful links

Downloads


Speakers
Sponsorship & supporting organisations
Venue
Hotel Taj Banjara

MEHFIL MAJLIS, Hotel Taj Banjara, Road No.1,Banjara Hills, Hyderabad, 500034, India

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