Risk and FDA Inspections: Anticipation, Preparation, Reaction and Conclusion

If you manufacture FDA-regulated drugs, devices, biologics, combination products, dietary supplements, or cosmetics the underlying reason FDA will inspect your facility is to determine if you are in control of all aspects of the operation. It is not enough to have SOPs that state what is supposed to happen. FDA starts with your products and then works backward to determine if all the pieces are in place. For contract manufacturers, the challenge grows exponentially as the number of clients and products increases.

Speaker: John Misock | View Anytime | Duration: 90 Minutes | Price: ¤199.00 | View Details