The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.
To this end, this accredited course is intended to help you better understand and get familiar with best practices for FDA approval process for quality risk management (QRM) applicable for pharmaceutical industry. This webinar is further intended to discuss how risk management plans can be effectively integrated into a quality system (QS) in the pharmaceutical industry.
This training will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry. In addition, this course will help the attendees develop and implement a systematic and holistic risk management strategy integrated into the quality system.
Attendee Reviews
“Excellent. Danielle did a wonderful job presenting the course.”
“This course had provided me with the knowledge and training required to be successful in my role at [my company], which requires me to apply the principles of Quality Risk Management in solving compliance issues.”
Upon completion of this course, participants will be able to:
This training is part of a 10 course (15 hour) series required for the FDA Inspection Readiness Certification. Attend this training as a step in the certification process or as a stand-alone course for personal career advancement and training.
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This course will be valuable to all individuals working within or managing a manufacturing program that supports either the R&D development of a new drug product or the manufacture of commercial drug product released to the market and would be beneficial to professionals in:
Regulatory affairs personnel as well as individuals who are responsible for the review or audit of such inspections and reports would likewise find this course very worthwhile.
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
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