Expert Profile
Nanda Subbarao
Senior Consultant, Biologics Consulting Group
Dr. Subbarao, holds a Ph.D. in Bio-organic Chemistry. She is currently a Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. Her hands-on industrial experience covers stability and laboratory cGMP systems for both biologics and conventional drugs. As a consultant she has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products ranging from conventional drugs to well characterized proteins and vaccines, from pre-clinical phase to commercial phases. She has been involved several times over her career in projects to setup or upgrade cGMP/GLP complaint Quality Systems for laboratory and stability programs for products during development and in commercial phase. She serves on the AAPS Stability Focus Group Steering Committee.
Trainings by Expert
Best Practices for Conducting OOS Investigations (in Pharmaceutical Laboratories)
Category:
Drugs and Chemicals (Pharma)
,
Laboratory Compliance
,
All FDA Regulated Industry
,
Testing and Validation
,
Quality and Safety
,
Laboratory
,
Analytical Laboratory
,
Best Practices & GXPs
,
Life Sciences
Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Category:
Biotechnology
,
Biologics and Biosimilars
,
Life Sciences
Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages
Category:
Biotechnology
,
All FDA Regulated Industry
,
Testing and Validation
,
Documentation and IT
,
Quality & Safety
,
Biologics and Biosimilars
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life Sciences
Forced Degradation Studies/ Biologics Stability Programs for Biopharmaceuticals
Category:
Drugs and Chemicals (Pharma)
,
Biotechnology
,
Testing and Validation
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Technologies and Processes
,
Biologics and Biosimilars
,
Life Sciences
Why and How - Verification of Compendial Methods - USP <1226>
Category:
Drugs and Chemicals (Pharma)
,
Quality and Safety
,
Supply Chain and Manufacturing
,
Life Sciences
Full Day Virtual Seminar : Annual GLP Refresher Webinar
Category:
Laboratory Compliance
,
Laboratory
,
GLP & Other Best practices
,
Life Sciences
4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs
Category:
Drugs and Chemicals (Pharma)
,
Biotechnology
,
Laboratory Compliance
,
All FDA Regulated Industry
,
GXP Pharmaceutical
,
Quality and Safety
,
Laboratory
,
Quality & Safety
,
Drugs Regulations
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
Common FDA Regulations
,
QA/QC
Annual GLP Refresher Course - 4 Hour Virtual Training
Category:
Laboratory Compliance
,
All FDA Regulated Industry
,
Testing and Validation
,
Quality and Safety
,
Laboratory
,
Contamination Control
,
GLP & Other Best practices
,
Microbiology Laboratory
,
Analytical Laboratory
,
Life sciences QA/QC
,
Regulations & Guidances
,
Best Practices & GXPs
,
Life Sciences
,
Regulatory Affairs
,
Common FDA Regulations
,
QA/QC
Annual Analytical Laboratory Data Integrity Training
Category:
Laboratory Compliance
,
Quality and Safety
,
Laboratory
,
Analytical Laboratory
,
GCP & Other Best Practices
,
Audit & Inspection-Role
,
Lab Audit
,
Documentation and Policy Management
,
Lifescience process & Procedures
,
Life sciences QA/QC
,
Regulations & Guidances
,
Life Sciences
,
Regulatory Affairs
,
Documentation and Data Management
,
QA/QC
Stability Program for Pharmaceuticals and Biologics
Category:
Drugs and Chemicals (Pharma)
,
Biotechnology
,
Laboratory Compliance
,
GXP Pharmaceutical
,
Quality and Safety
,
Laboratory
,
Microbiology Laboratory
,
Quality & Safety
,
Biologics and Biosimilars
,
Drugs Regulations
,
Biotech Regulations
,
Life sciences QA/QC
,
Research & Development
,
Drug R & D
,
Regulations & Guidances
,
Regulatory Affairs
,
QA/QC
