FDA and MHRA Pharmacovigilance Inspection Readiness and Management


Instructor: Kathleen Humel
Product ID: 704181

  • Duration: 60 Min
This discussion is geared for the pharmaceutical industry. It will provide pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and development and quality and compliance groups in the pharmaceutical industry would benefit from tips discussed in this session as well.
Last Recorded Date: Nov-2015


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Why Should You Attend:

This webinar is for anyone working in a regulated environment such as pharmacovigilance, medical information, quality and compliance or research and development. There is a very good chance that you will be inspected by a health authority, maybe you have been inspected already and you are anticipating their return. This webinar will give you tips needed to get your department in shape for inspectors and learn how to handle the inspection with ease.

Areas Covered in the Webinar:

  • FDA and MHRA health authority inspection preparation suggestions for pharmacovigilance departments
  • What to expect before, during and after the inspection
  • How to manage the inspection and run the back room
  • How to address the inspection report

Who Will Benefit:

  • Pharmacovigilance/ product safety departments
  • Medical information groups
  • Research and development groups in the pharmaceutical industry
  • Quality and compliance groups in the pharmaceutical industry

Instructor Profile:

Dr. Kathleen Humel holds a doctor of pharmacy degree and is a licensed pharmacist. She worked as a retail pharmacist, pharmacy manager and trainer for eight years for independent as well as chain pharmacies. She ventured into the pharmaceutical industry and has remained there for 14 years. Dr. Humel worked as a drug safety associate and gradually worked her way up to a management position, overseeing a pharmacovigilance document management group for several years. She began working as an independent pharmacovigilance consultant, then started RX KHumel, LLC consulting company, specializing in pharmacovigilance and cross functional area procedural document development, document hierarchy structure development, inspection and audit preparation and support, compliance, quality assurance, corrective action and preventive action (CAPA), Pharmacovigilance System Master File (PSMF) management and training.

Topic Background:

Inspection readiness reviews areas of focus for when a pharmacovigilance department is preparing for an FDA or MHRA health authority inspection in order for the department to be prepared for an inspector to walk in. Inspection management reviews practices that can be implemented before, during and after an inspection in order to ensure efficiency and accuracy. The department must ensure that the inspector’s requests are met in a timely manner and the pharmacovigilance department is ready to accept, track and respond to onsite inspector requests. The goal is to have a pharmacovigilance department that is ready for an inspection at any given moment. Product safety is an essential aspect of everyday business when marketing drugs, devices and over the counter products. Health authorities implement strict regulations and it is the duty of the pharmaceutical industry to adhere to these regulations and keep patients safe.

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