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Event :Seminar on Hosting FDA Regulatory Inspections in San Diego

Dates :Thursday September 20th, 2018 - Friday September 21st, 2018

Location :WILL BE ANNOUNCED SOON
San Diego, United States

Type :Education - International audience

Accreditation :--


 

Further information

 

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%)*

 

 


Location

Map and directions
Education address :
WILL BE ANNOUNCED SOON
San Diego
United States
Map and directions

Further information

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Announcer

GlobalCompliancePanel
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and [...]

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Details

Seminar on Hosting FDA Regulatory Inspections in San Diego General medicine - Hospital - Pharmacy
fda inspection, fda compliance, fda regulations
Regulatory Affairs professionals Quality Assurance Physicians Nurses Lab Technicians Operations Clinical Data Management Laboratory Management Manufacturing IT
50 1 1
English

Other

For more information on Seminar on Hosting FDA Regulatory Inspections in San Diego, plsase contactr GlobalCompliancePanel

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