The webinar will also illustrate the lifecycle management of analytical procedures and train attendees on documentation requirements to ensure Data Integrity.
Why should you Attend:
The guidance changes how FDA regulated methods will be developed, validated and used. Additionally, how to ensure Data Integrity will be discussed. The webinar will focus on detailing all key components of the guidance and analyze its validation parameters, tests, and acceptance criteria with respect to Data Integrity.
Areas Covered in the Session:
Scope and Content of the Guidance
Performing Pre-Validation Studies
Analytical Method Transfer Studies
Data Integrity and Documentation Requirements
Who Will Benefit:
Contract Laboratory Staff
Laboratory Managers and Staff
QA Managers and Personnel
Regulatory Affairs Personnel
Gary Miller has over 20 years in the R&D and manufacturing areas in the pharmaceutical industry. Gary’s hands-on experience includes investigations (product and manufacturing), product development, manufacturing, quality, auditing, regulatory, project management, and laboratory management.
Find more here: www.compliance4all.com