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Seminar on Hosting FDA Regulatory Inspections in San Diego


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Who should attend?

Nurses Lab Technicians Operations Clinical Data Management Laboratory Management

Details

Description:

Why you should attend:

The course will go through what typically goes on during an FDA inspection and will then cover how to prepare for, host and follow up to a regulatory inspection. It will focus the things that you should do or not do during the inspection. Typically FDA inspections can be highly structured and there are usually procedures that are to be followed. It is important for anyone who might be involved in the inspection to be aware of these procedures.

The course will also provide information for inspections conducted by international agencies as well as non- FDA agencies, including self inspections for manufacturing. It will explain how to prepare for an inspection, how to handle a scheduled or non-scheduled inspection, what to expect during an inspection and what follow up to expect after an inspection.

Finally, the course will provide information on how to respond to issues that come up during inspections and what to do to ensure best outcome from the inspection.

Who will benefit:

Anyone who would be involved in the trial

  • Regulatory Affairs professionals
  • Quality Assurance
  • Physicians
  • Nurses
  • Lab Technicians
  • Operations
  • Clinical Data Management
  • Laboratory Management
  • Manufacturing
  • IT

Agenda:

Day 1 Schedule

Lecture 1: FDA Inspections: FDA Inspection Program Overview

Lecture 2: FDA Inspections: Key factors for a successful FDA inspection

Lecture 3: FDA Inspections: Quality System Readiness

Lecture 4: FDA Inspections: Information Readiness

Lecture 5: FDA Inspections: Organization Readiness

Lecture 6: FDA Inspections: Manage Inspection Outcomes

 

Day 2 Schedule

Lecture 1: FDA Inspections: Managing Regulatory Risk

Lecture 2: FDA Inspections: Food Facility Inspections

Lecture 3: FDA Inspections: Medical Device Inspections

Lecture 4: FDA Inspections: 21 CFR 11 Inspections

Lecture 5: FDA Inspections: FDA Quality Metrics

Lecture 6: FDA Inspections: CAPA

Lecture 7: FDA Inspections: Writing Effective SOPs

 

Speaker:

Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

Seasoned Executive with 40 years of experience in the Life Sciences & Healthcare Industries. Positions include Chief Compliance Officer. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Co-authored & prototyped 21 CFR 11 guidance with FDA.

 

Location:  San Diego, CA Date: September 20th & 21st, 2018 and Time: 9:00 AM to 6:00 PM

Venue:  WILL BE ANNOUNCED SOON

Price:

Register now and save $200. (Early Bird)

Until August 20, Early Bird Price: $1,295.00

From August 21 to September 18, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (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=901885SEMINAR?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

Prices

Register now and save $200. (Early Bird) Until August 20, Early Bird Price: $1,295.00 From August 21 to September 18, Regular Price: $1,495.00 Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

Contact

Event Manager
john.robinson@globalcompliancepanel.com

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