91AV

Introduction

      ► 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​
• Scientific real time decision making.

     ► Bio statistics :

•  Bioequivalence statistical analysis in 3 steps
•  Bioanalytical outlier
•  Chromatogram sample selection method

     ► Medical writing 

• Scientific report writing (clinical trial document to clinical trial report)

Deadlines

• Jun 15 2017
  Early bird registration deadline

  
• Jun 29 2017
  Standard registration deadline

  

Useful links

Downloads

• Bioanalytica 2017 Conference Brochure

Speakers

• Robert Bethem Consultant-RAB consulting, India
• Dr.Nirali Mehta Director of PHARMA-STATS ,Gujarat, India
• Dr.Amarnath Jaiswal Associate VP & Head Bioanalytical of Mylan laboratories, India
• Dr. Hetal Shah Independent Medical writer, Pharmacologist , India
• Dr.Neil Spooner Founder &Director Spooner Bioanalytical Solutions, United Kingdom
• Dr.Manish Yadav CEO - ETHIXINN Consulting & Research Solutions , India
• Dr. Smita Belwalkar Head - Audit & Compliance EISAI Pharmaceuticals India , India

---

Sponsorship & supporting organisations

---

Sponsors

Venue

Hotel Taj Banjara

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

Useful links

Organised by

Contact information

Sridhar Thandra
ABC Biologics
Plot No B/345,Prashanth nagar ,Vanasthalipuram,Hyderabad-500074
+919396665735
Contact us by email

---