Register for this Class   Bring Course On-Site

2-Day Course
Navigating the Path to State Licensing

---

Understanding the entire process from start to completion

With the recent State licensing issues for many areas of Pharmaceutical and healthcare research, manufacturing and distribution, it’s imperative that you are properly licensed on State level as well as meeting FDA requirements.  This program will provide you that thorough understanding of the similarities and differences between FDA and State Requirements, who to effectively meet both, all questions will be covered in detail such as: who and what needs to be licensed on State level, the process that needs to take place and the follow through required.  Understand your roles and responsibilities as a manufactur4ers, wholesalers, re-packagers to any area of drug and healthcare environment.  Know if VAWD certification is right for your organization, learn the best way to maintain licensing efficiently across multiple state lines and how to avoid state regulatory actions.

---

Course Outline

Course Overview and Learning Objectives

Speaker Qualifications

General Overview of State Licensing – How did it all begin?

• The History and Origination of the State Licensing Requirement
• FDA vs State Requirements
• State to State Variations

Who needs a License?

• Manufacturers
• Repackagers
• Distributors, Wholesalers
• Other Classifications

How Does a Company Beginning the Process?

• Knowing Your Type of Operations
• Knowing Where You Obtain Your Materials
• Contacting the State
• Viewing the State Websites

Getting Started

• Obtaining the Application
• Reviewing the Requirements
• Preparing a Spread Sheet
• Getting Management Cooperation

What is the VAWD?

• VAWD Overview
• VAWD Certification – A Future Reality

Completing the Application

• Copy of Current State License
• Verification Process
• Background Checks
• Fingerprinting
• Other Accompanying Forms
• Notary Services
• Fees

Examples of How State Applications and Requirements Differ

• Maine
• Florida
• California
• Nevada

Maintaining Organization after Submission

• Keep a Spread Sheet
• Check Expiration Dates
• Check Renewal Process

Staying On Top of the Changing State Regulation

• Obtaining a Copy of the States Rules and Statues
• Review Websites Periodically

cGMP Training Credit

• Competency Assessment Performed to Ensure All Attendees Fully Understand All Concepts Presented and Can Implement Them Before the End of the Training Course
• Documented Training Verification Provided Using Our Own Training Forms or Your In-House Training Form To Address FDA’s Requirement of Periodic cGMP Training

Free 1 on 1 Consulting From the Industry’s Top Expert

Confidential One On One Consulting/Assistance at the End of the Course For Those That Sign Up In Advance at No Additional Cost.

Get Answers to your Specific Situation Questions Without Airing your Firms “Laundry” to the Group

---

Who Should Attend

Professionals who will be most assisted by this course include:

• Managers
• Directors of Quality
• Directors of Regulatory Affairs
• CEO’s
• Presidents of Drug and Device Companies.