In this FDA inspection webinar attendees will learn the basic understanding of Active Pharmaceutical Ingredient Good Manufacturing Practices (ICH Q7) and the most important elements of API GMP to avoid serious deviations and failures during either a Pre-Approval or GMP Inspection.
Attending and implementing what is discussed during this program has shown itself to help companies not only avoid embarrassing situations, wasted time, while improving product quality, reliability and effectiveness.
Attending this program improves your ability to better prepare for a successful FDA inspection:
It is important, that First level personnel should always understand, through other training, what is expected during an inspection or an audit!
Why Should You Attend:
Preparing properly for an FDA inspection, is the most cost effective way to be successful during an FDA inspection. The costs associated with this program or applying corrective actions prospectively at this point, is a firm’s best way to minimize wasted efforts and expenses.Attending and implementing what is discussed during this program has shown itself to help companies not only avoid embarrassing situations, wasted time, while improving product quality, reliability and effectiveness.
Attending this program improves your ability to better prepare for a successful FDA inspection:
- Will help participants be better prepared to complete a regulatory review of an API site
- Learn where to focus corrective actions
- Find “the smoking guns” at a facility or site
- How to improve a site’s readiness for an FDA inspection
- Identify and avoid “Smoking Guns” during inspections
- Learn where to focus your attention to minimize or eliminate problems during an API Audit or inspection
- This program will help you identify a process to follow, what to avoid and how to enter and exit from an FDA inspection successfully.
Areas Covered in the Webinar:
- Discusses what will be covered during this program
- What is the most critical understanding needed for success
- Suggested process to follow including: what to review before and during the audit
- What and where to look
- No smoking guns observed
- No Data Integrity Issues Observed
- Review all appropriate areas including Critical Operations/Systems/Records
- How the Audit should Start and End
- Where are the key areas and systems
- Opening/Ending/and Follow-up Actions to the Audit
Who Will Benefit:
The Target audience should include Quality, Manufacturing, Engineering, Distribution, and regulatory management and key personnel. Paricipants would be from Firms that produce, consume, ship or store API. Attendee should come from Directors, Managers, Supervisors or personnel that are responsible for any GMP related function for a firm above the first level are potential candidates for attending this program.It is important, that First level personnel should always understand, through other training, what is expected during an inspection or an audit!
Speaker
Max LazarCourse Provider
Max Lazar,
