Speaker Profile

John Misock
John Misock
Senior Regulatory Consultant,

John Misock As an accomplished leader across multiple FDA-regulated industries, John uses his broad experience to help clients obtain the best possible outcomes when faced with regulatory challenges. John’s ability to get to the heart of the matter gets quick, accurate, and cost-saving results.

Whether responding to FDA warning letters or instituting a corporate-wide QMS, John’s previous FDA experience provides a unique perspective on compliance with regulatory requirements. His understanding of the FDA’s prior approval processes for drugs and devices would be an asset to any firm considering marketing new or rebranded products.

Expertise
• Regulatory compliance
• QMS
• NDA/ANDA
• IND
• 501k
• International regulatory compliance, ICH, MDR

Upcoming Webinars Recorded Webinars
John Misock

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
John Misock

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: ¤399.00 | View Details