​​​​TRAINING & CERTIFICATIONS 

In recent years, there has been a dramatic growth in FDA compliance and regulatory requirements. Since regulatory knowledge is valuable to help reduce development time and prevent costly mistakes and audits, it is essential to be updated and to understand how to apply this knowledge during the various phases of development.

Our unique workshops are designed to provide employees and management with a foundation and essential background in FDA regulatory law, as well as updates in new and relevant guidelines.

Our workshop training is available at your location and offers detailed training on a given topic selected by your organization and delivered by a team of experts in the field.

WORKSHOP 1

Understanding FDA Regulation - THE SIX CORE REGULATIONS

21 CFR 11 - Electronic Records & Signatures
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure
21 CFR 56 -  Institutional Review Boards

​21 CFR 312 - Investigational New Drug Application (IND)

21 CFR 314 - New Drug Application (NDA)

WORKSHOP 2

505(b)(2) - Practical Strategies to a successful 505(b)(2) product

WORKSHOP 3

FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND

WORKSHOP 4

Labeling for Human Prescription Drug and Biological Products

WORKSHOP 5

Clinical Considerations - The Clinical Protocol (Design & Endpoints)

​WORKSHOP 6

FDA Expedited Programs - Fast Track Designation,

Breakthrough Therapy Designation, Accelerated Approval Pathway, Priority Review Designation 

WORKSHOP 7

Clinical and Regulatory Considerations for Orphan Drug Applications

WORKSHOP 8

The Sponsor, Investigator and IRB Responsibilities - Regulations in Clinical Trials  

WORKSHOP 9

FDA Meetings - Communication & Collaboration Channels with the FDA

WORKSHOP 10

 FDA Inspections - How to make a FDA Inspection as Painless as Possible