USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP
Gregory Martin
90 Min
Product Id: 703521
This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.
Creating FDA-compliant cGMP Training Program
Henry Urbach
60 Min
Product Id: 703401
This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.
FDA Inspection Preparedness
Susan Muhr Leister
60 Min
Product Id: 704221
This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance
Gaurav Walia
75 Min
Product Id: 704370
This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Michael Ferrante
90 min
Product Id: 703538
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
Auditing Analytical Laboratories for FDA Compliance
Michelle Sceppa
60 Min
Product Id: 701325
This Analytical laboratory audit training/webinar will show how to implement a GXP program and how to audit this program.
Avoiding FDA observations: Do's and Don'ts during Laboratory Inspections
Kim Huynh-Ba
Product Id: 703278
This training will provide the attendees best practices for handling FDA inspections to avoid form 483 and Warning Letters.







