Seminar on Hosting FDA Regulatory Inspections in San Diego
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 ScheduleLecture 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
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
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Outline
Special Offer
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%)*
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.
GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:- Risk Management
- Regulatory Compliances
- Corporate Governance
- Quality Management
Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. In the 10 years for which it has been in the professional trainings industry; GlobalCompliancePanel has developed a rich legacy of courses. It boasts an amazingly large repertoire of 5000 courses, which consist of over 2000 in-person seminars. ...