Proper Management of Regulatory Inspections

Thursday, May 11, 2017 at 1:00PM - 2:00PM
Item Name Price Each Fee Each Items Left Qty to Buy
Live Session $199.00 $7.04 50

Event Details

Overview:

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.

Why Should You 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 this Webinar:

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

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.

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

Speaker Profile:

Danielle DeLucy, MS, is an Independent Consultant to the Biologics and Pharmaceutical Industries.

Danielle DeLucy, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance.Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. 

For more detail please click on this below link:

http://bit.ly/2ooxA31

Email: referrals@complianceglobal.us
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

Fax: +1-516-900-5510

Organization Details

ComplianceGlobal.us:

Offering a different perspective, that leads to something exceptional.

Compliance Global Inc; is a training organization based in New Hyde Park, New York, providing world-class regulatory and quality control compliance trainings by leveraging a pool of experienced speakers / consultants in the Pharmaceutical, Bio-Technology, Medical Devices, Clinical Compliance, FDA Compliance, Healthcare & HR streams for customers in the North American geographical area. These trainings are contemporary, simple and cost-effective with easy access and great delivery experience.
Compliance Global is a multifaceted entity, an absolute knowledge repository. The work ethics of Compliance Global is to focus on individuals’ productivity first and this to become a by-product of the teams’ productivity. At Compliance Global, we believe that experience doesn’t have to mean old ideas – we believe in bringing fresh ideas, fresh perspectives to instill confidence in you.
Through our online trainings, we provide a world of certainty, surety and consistently deliver confidence to all the attendees. 
Working as one, we are on a path breaking drive to redefine the Webinar training space through delivery innovations, reliability and service efficiency.

Through our online trainings, we provide a world of certainty, surety and consistently deliver confidence to all the attendees. 

Working as one, we are on a path breaking drive to redefine the Webinar training space through delivery innovations, reliability and service efficiency.

With unmatched quality and unequalled service we provide superior trainings for individuals who are in the business of winning. 

We help winners look for solutions that unlock the potential of knowledge to match business needs.

We not just understand your needs better but help deliver what winning individuals need - timely, relevant and accurate information.

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Online Training
2754 80th Avenue, New Hyde Park, NY 11040

Starts May 11, 2017 at 1:00PM - 2:00PM

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Contact Information

Organization: Compliance Global Inc

Event Contact: Compliance Global Inc.

Phone: 5169005515

Organization Web Site:
http://www.complianceglobal.us/

Location Web Site:
http://bit.ly/2ooxA31