8:30 – 10:00 GLP - Bioanalysis 

• Prerequisite and Requirements for GLP-Bioanalysis
• Establish GLP Bioanalytical Lab
• Develop Bioanalytical Methods
• Validate Bioanalytical Methods under GLP Regulations
• Perform GLP-Bioanalysis in regulated environment
• Course will present material from conducting GLP-bioanalysis in modern state of the art bioanalytical facility operating under industry highest standards and practices.
• Course participants will gain inside knowledge into working procedures of GLP-bioanalysis in support of IND-enabling and clinical studies and their impact on drug development program
  

Tutor:
Eckhardt Schmidt, Ph.D., Principal Scientist, Clinical Pharmacology and DMPK, AstraZeneca Pharmaceuticals LP
Dr. Eckhardt Schmidt earned his Ph.D. in chemistry at Philipps University/Germany and attended Kansas and PennState University for postgraduate research. Dr. Schmidt has held senior scientist and managerial positions with contract research organizations and major pharmaceutical companies at Ricerca Biosciences, IVAX, Metabais Therapeutics and AstraZeneca. His proven track record of 13 years has provided a unique “hands-on” perspective on bioanalytical applications. He has been recognized by problem solving and extensive accomplishments in GLP Bioanalysis to support drug discovery efforts. Dr. Schmidt manages at AstraZeneca the GLP LC/MS/MS laboratory by developing and validating methods and overseeing bioanalysis to deliver nonclinical, in vitro and clinical studies. His work experience include dose-ranging, relative bioavailability and drug drug interaction studies on small molecules in a high-through-put environment.



DOCUMENTATION, VALIDATION AND QUALIFICATION

10:00– 11:30 am

Building a GLP-Compliant Business from the Ground up - Avoiding Common Pitfalls
Tutor:
Ray l. Nunnally, Ph.D., Invivometrics

11:30 – 11:45 Coffee Break

11:45 – 1:15 pm Current Trends in Bioanalytical Method Validation or Validation of Computerized Systems - A Risky Business?
Current requirements/process: Method development/validation Setting up a method validation protocol Update on the “Crystal City” requirments Method transfer/revalidation - how to Current trends from the OECD or Primer on validation of computerized systems - requirements by the GLPs GAMP5, PIC/s and other guidelines Red Apple II - current concepts for validation of computerized systems FDA, 21 CFR Part 11and the risk based approach.  The tutorial gives a comprehensive way an up-to date picture of method validation and validation of computerized systems in a GLP setting.  Attendees will be able to implement and use the concepts and principles associated with bionalaytical method validation and validation of computerized systems in their own GLP environments.
Tutor:
Wolfgang Seidel, Ph.D., MRQA, Head of QA DMPK, MSR Nonclinical Development, Merck KGaA
Dr. Seidel received his Ph.D. in food chemistry and has 8 years of experience in several QC/QA functions in the biotech/pharmaceutical industry Currently head of QA for the GLP test facility DMPK Merck KGaA Member of the BARQA, DGGF, GDCh and DGQ Speaker at various national/international CSV/GLP conferences.

1:15 End of Course

Day 1