Quality Assurance and Regulatory Aspects of HPLC in Quality Control

Why Should You Attend:

This presentation will help you meet FDA, ICH and other regulatory requirements for the Quality Assurance and Quality Control for Testing of Pharmaceutical API and or Nutritional Supplement ingredients to validate potency claims. It will help you better understand how to meet and maintain these requirements in a cost effective way to avoid adverse audit findings.

Learning Objectives:

• To understand the regulatory requirements for cGLP cGMP HPLC analysis and the reasons for them
• To learn of cost effective ways to implement and maintain the required compliances
• To understand why analyses performed with systems not properly Qualified and or using methods that are not properly validated will result in questionable results, adverse audit findings, and jeopardize the validity of QC and Stability Testing results necessary for correct product testing and release.

Who will Benefit:

This webinar will provide valuable assistance to all personnel in:

• Pharmaceutical and Nutritional Supplement Manufacturer's Quality Assurance
• Quality Control Laboratory Management and Professional Staff
• cGMP Manufacturing Management and Professional Staff
• Regulatory Affairs

Neal H. Wright, has over 35+ years of professional experience in the utilization of HPLC in Quality Assurance and Quality Control in the Life Sciences, Biotechnology, Pharmaceutical and Medical Diagnostics fields including the use of HPLC for clinical medical diagnostic laboratories for Therapeutic Drug Monitoring (TDM) and Toxicology testing. The presenter has extensive experience with a large variety of HPLC systems with different configurations from numerous manufacturer's and has developed great expertise in the applications of HPLC systems for Bioanalytical and Biochemical analyses.