Tuesday May 7, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Danielle DeLucy
Background:
The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This webinar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol for setting up the Inspection room and any associated “war” rooms that will support the inspection, and how to manage requests from the investigators in a timely and accurate manner. This preparation minimizes stress and disorder during the inspections.
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
This webinar will analyze each of these necessary elements of the batch record review process.
Why You Should Attend:
To learn the how to set up support groups/rooms for the inspection.
Learn how to properly communicate with the inspector
To be able to organize requests from the inspectors and process them in a timely and accurate manner.
Know what is expected of you and your company
Learn what not to say or do during an inspection.
To learn how to use your internal Quality Assurance groups to help identify issues prior to an inspection.
Areas Covered in the Seminar:
- Pre-planning and preparation activities
- What to do when the investigator arrives
- What documents to have ready and on hand
- Assignments and responsibilities for the inspection
- A review of Inspection Do’s and Don’ts
- The Opening and Close-out Sessions
Who Will Benefit:
Site Quality Operations Managers
Quality Assurance personnel
Plant Managers and Supervisors
Manufacturing Superintendents and Managers
Individuals whose job knowledge and/or expertise may be called upon during an audit
Regulatory Affairs Managers
Learning Objectives:
Upon completion of this session, attendees will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the audit.
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-592