FDA Inspections 2015 - Regulatory Inspections: The Art of Managing the Investigator

Overview:
This webinar will provide attendees with the information and tools necessary to effectively develop and implement a process to manage regulatory inspections and investigations.
Hi, I'm from the [insert regulatory agency]; I'm here to help you!" Having an unannounced visit from the FDA, USDA, OSHA, or a myriad of other agencies is not a great way to start the day; however, knowing how to effectively manage the visit and ensuring that your rights are clearly understand and protected will go a long way in making the process less nerve-wracking. Not knowing the agency's limitations and restrictions can provide them with information that they have no right to access and be used against the company and its management team.
Learning Objectives:
Understand the rights of the manufacturer/distributor during regulatory inspections and investigations
Understand the rights of the regulatory agency during inspections and investigators
Develop a process to effectively manage regulatory inspections and investigators
Developing the right team
Areas Covered in the Session:
Types of Regulatory Inspections
Developing the Team to Manage the Investigation
Before the Investigator Arrives
Visitor control
Processing of Regulatory Auditors, Inspectors, and Compliance Officers
Opening Conference
The Audit and Inspection
Closing Conference
Notifications
Follow-Up Proceedings
Postings
Who Will Benefit:
Quality Assurance/Quality Control Directors and Managers
Regulatory Affairs/Regulatory Compliance Directors and Managers
Executive Management
Operations Directors and Managers
Human Resources Directors and Managers
Environmental Health and Safety Directors and Managers
Speaker Profile
Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link: http://bit.ly/1HZxZ36
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