The FDA PADE inspection is an integral part of the FDA safety surveillance program for FDA-regulated drug and therapeutic biologic products. The PADE inspection is administered under the FDA Compliance Program, specifically, as part of program 7353.001: CHAPTER 53 – Postmarketing Surveillance and Epidemiology: Human Drug and Therapeutic Biological Products.

This course will provide attendees with a general understanding the PADE inspection, the impact on pharmacovigilance and the overall organization and how to effectively prepare for, participate in and respond to the PADE inspection from a pharmacovigilance perspective.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

• Understand the PADE inspection in relation to the organization’s product approval
• Explain what being inspection ready means
• Understand how to effectively prepare your pharmacovigilance team for the PADE inspection
• Identify how to effectively plan for a PADE inspection
• Planning for gaps that may come up during a PADE inspection
• Understand how to interface with the PADE inspector
• Determine how to respond to PADE inspection findings
• Understand how to continue effective inspection readiness following the PADE inspection

Course Outline

• Module 1: The PADE Inspection explained and understanding why they are performed
• Module 2: The scope of the PADE inspection in relation to your company
• Module 3: Preparing for the PADE inspection
• Module 4: Participating in the PADE inspection
• Module 5: Responding to pharmacovigilance observations identified during the PADE inspection
• Module 6: Maintaining inspection readiness following the PADE inspection

Who Should Attend

• Business Development Personnel
• Commercial Personnel
• Heads of Pharmacovigilance Departments
• Heads of Pharmacovigilance Operations
• Marketing Personnel
• Medical Affairs Personnel
• Other Personnel that would participate in the PADE inspection
• Quality Assurance personnel
• Regulatory Personnel

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Heather Murphy, R.N., M.B.A., CQA

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Course Length and Time

4 weeks for 4 hours each week.

Registration Fees

$1,795 by Early Bird Deadline

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 16 hours (1.6 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-25-059-L99-P. Released: 9/25. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.