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10th International Seminar
FDA Inspections, Warning Letters, & CAPA 2015 Update
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| Wednesday, 30th September, 2015, Princeton, NJ, (Unable to "Travel"!! Attend Online as webinar) |
| Presented By : J. Lawrence Stevens, RAC, FDA Regulatory Expert, One Way Consultants, LLC |
Register Now |
Duration : Full Day (09:30 AM - 04:30 PM EST)
Followed By Lunch, Tea Sessions & Q/A Session
Copy of presentation slides & certificates will be shared. |
Online participation available
Space is Limited!!! |
| Program Agenda: |
| 9:00 AM – 09:30 AM |
Breakfast + Introduction |
| 09:30 AM - 10:30 AM |
Current FDA Inspection, Enforcement Trends, and Field Issues:
- How FDA establishes inspectional priorities
- Current Agency, CDRH, and District inspection and enforcement focus
- Profile of recent warning letters and 483s
- Supply chain issues
- Other issues of present and growing concern
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| 10:30 AM - 10:45 AM |
Tea/Coffee Break |
| 10:45 AM - 12:15 PM |
Managing the FDA Inspection:
- Preparing for an impending inspection
- Assembling the team – who should be there
- Managing documents – what needs to be available
- Training all employees on proper inspection rules and etiquette
- FAQs – photographs, recordings, etc.
- What to do if something goes wrong
- Inspection close-out and on-site agreements
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| 12:15 PM - 01:15 PM |
Lunch |
| 01:15 PM - 02:00 PM |
Introducing CAPA
- Definitions and requirements: how to keep it simple
- Key CAPA concepts and how they fit into the overall quality system
- The relationships among risk management, CAPA, and design process
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| 02:00 PM - 02:45 PM |
When to Use CAPA
- When to initiate a CAPA
- How to apply risk management in the CAPA process
- Prioritization
- Resource allocation
- Metrics
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| 02:45 PM - 03:00 PM |
PM Break |
| 03:00 PM - 04:30 PM |
PM FDA’s Enforcement Actions:
- FDA Criteria for Determining What Items to List on a 483
- When the Agency Will Issue a Warning Letter
- Interactive Session: How to Respond to 483s and Warning Letters
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| 04:45 PM - 05:00 PM |
Q&A – Conclusion
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| Venue/Location: |
NJHA Conference & Event Center
760 Alexander Road, PO Box 1
Princeton, New Jersey
view location map |
| Speaker: |
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J. Lawrence Stevens, RAC
FDA Regulatory Expert
One Way Consultants, LLC |
For registration fees, discounts or any information, please Contact Us at:
marketing@biopractice.com |
| Registration Information: |
- Registration Fees : USD 699 - Group Registration also available.
- For any further information, please, Click Here
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| Register Now |
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