I. Review Essential GLP Principles
II. Define Personnel Responsibilities for GLPs
III. Handle Test and Control Articles
IV. Develop GLP Compliant Standard Operating Procedures (SOPs)
V. Ensure Document Control for GLP Studies
VI. Ensure GLP Compliance for Equipment and Logs
VII. Validation of Automated Data Collection Systems
VIII. Comply with Part 11-Electronic Records and Electronic Signatures
IX. Comply with BioAnalytical Laboratory Requirements
X. GLP Compliant Data Audits
XI. Perform In-process Inspections
XII.Prepare QA Inspection Reports
XIII. Prepare for the GLP Inspection
12(hours)