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How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

Event Details

How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

Time: September 26, 2018 at 9am to September 27, 2018 at 5pm
Location: Courtyard Arlington Crystal City/Reagan National Airport
Street: 2899 Jefferson Davis Highway Arlington
City/Town: Washington
Website or Map: https://www.globalcompliancep…
Phone: 800-447-9407
Event Type: seminar
Organized By: NetZealous LLC DBA GlobalCompliancePanel
Latest Activity: Jul 19

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Event Description

Description:

Senior management takes responsibility for Quality and GXP compliance. It is not something delegated to the Quality unit or to the Regulatory Affairs group. Developing and implementing an effective Inspection readiness plan will help ensure better results, as well as a less stressful inspection. Planning strategically ahead will reduce document turn-around time, improve presentation skills from SMEs, and increase inspector confidence in the Quality System. Successfully completing an FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection Management techniques can help mitigate the risk of receiving an observation for compliance gaps. Quality and GXP compliance are an opportunity, not an obligation, and are owned by everyone in the organization. For those interacting with FDA regarding submissions, as an example, every interaction with the FDA is a crucial moment for your development program, and meetings represent a culmination of compiled and scheduled work. Strategies, timelines, costs and complexity are all organized through this interaction - the stakes are high, and the outcomes are extremely important. It all comes down to strategic communication.

Location:  Washington, DC Date: September 26th & 27th, 2018 and Time: 9:00 AM to 5:00 PM

Venue:  Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Hwy, Arlington, VA 22202, USA

Price:

Price: $1,495.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $4,485.00 $7,475.00 You Save: $2,990.00 (40%)*

Register for 10 attendees Price: $8,222.00 $14,950.00 You Save: $6,728.00 (45%)*

Sponsorship Program benefits for seminar

For More Information- https://www.globalcompliancepanel.com/control/sponsorship

Contact us today!

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901747SEMINAR?seo

Follow us on LinkedIn: https://www.linkedin.com/company/globalcompliancepanel/

Like us our Facebook page: https://www.facebook.com/TrainingsAtGlobalCompliancePanel/

Follow us on Twitter: https://twitter.com/GCPanel

 

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