Seminar on Hosting Regulatory Inspections

Course "Hosting Regulatory Inspections" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

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:

CEO, Touchstone Technologies Silicon Valley 

Angela Bazigos, is the Chief Compliance Officer of Morf Media. She has 40 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in Virtual Validation of Software. She has been on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for contributions to the Lifesciences industry.

More recently, Ms Bazigos was quoted in the Wall Street Journal on Using Training to Bring Compliance to the Boardroom.

Location: San Francisco, CA Date: October 13th & 14th, 2016 Time: 9:00 AM to 6:00 PM

Venue: DoubleTree by Hilton Hotel San Francisco Airport

Address: 835 Airport Blvd., Burlingame CA 94010-9949, USA

Register now and save $200.

Price: $1,295.00 (Seminar Fee for One Delegate - Without stay)

Until September 10, Early Bird Price: $1,295.00 from September 11 to October 11, Regular Price: $1,495.00

Price: $1,695.00 (Seminar Fee for One Delegate - With stay)

Until September 10, Early Bird Price: $1,695.00 from September 11 to October 11, Regular Price: $1,895.00

Register for 5 attendees (With stay)   Includes    Price: $4,323.00 $8,475.00 You Save: $4,152.00 (49%)*

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com               

Website: http://www.globalcompliancepanel.com

Registration Link – http://bit.ly/2bvZ2p1-Hosting-Regulatory-Inspections

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