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FDA’s New Inspectorate Re-Org to Put Pressure on SMEs
This Webinar is over| Date | Feb 23, 2015 |
| Time | 01:30 PM EDT |
| Cost | $287.00 |
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Online
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If you think your Subject Matter Experts are stressed out now … then get ready for what's to come.
FDA’s new plans to create specialized teams of investigators — their composition and expertise based on your specific products — are going to put more pressure on SMEs than ever before. Are your SMEs ready?
It's not just about logistics any more – how you greet the investigator at the front door, should you offer him/her a glass of water or how many copies of key documents to make. The stakes are much higher.
Don’t miss FDAnews’ newest webinar, FDA’s New Inspectorate Re-Org to Put Pressure on SMEs, on Monday, February 23.
In just 90 minutes, you'll learn best practices and key points to ensure you have fully prepped your SMEs to address questions from the new specialized inspection teams.
You'll be taught the fine points of how to develop a comprehensive strategy based on assessed risks and train your SMEs to address these risks with the investigation team.
You'll learn such specifics as how to:
• Ensure your SMEs are aligned to the topics they are going to be asked the most
• Improve SME effectiveness by conducting thorough simulated inspection scenarios
• Satisfactorily answer questions commonly asked by investigators
• Avoid providing “extra information” that was not required to answer a question
• Successfully push back against FDA investigators' requests for documents
• Avoid angry responses, body language and tone of voice that can derail interviews
• And much more
Who Should Attend
• Compliance personnel
• Regulatory affairs professionals
• QA/QC personnel
• Potential SMEs for inspection
Conference Details:
FDA’s New Inspectorate Re-Org to Put Pressure on SMEs
**FDAnews Webinar**
Feb. 23, 2015 — 11:30 a.m. – 1:00 p.m. EST
Easy Ways to Register:
Online: www.fdanews.com/InspectorateReOrg
By phone: 888-838-5578 or 703-538-7600
FDA’s new plans to create specialized teams of investigators — their composition and expertise based on your specific products — are going to put more pressure on SMEs than ever before. Are your SMEs ready?
It's not just about logistics any more – how you greet the investigator at the front door, should you offer him/her a glass of water or how many copies of key documents to make. The stakes are much higher.
Don’t miss FDAnews’ newest webinar, FDA’s New Inspectorate Re-Org to Put Pressure on SMEs, on Monday, February 23.
In just 90 minutes, you'll learn best practices and key points to ensure you have fully prepped your SMEs to address questions from the new specialized inspection teams.
You'll be taught the fine points of how to develop a comprehensive strategy based on assessed risks and train your SMEs to address these risks with the investigation team.
You'll learn such specifics as how to:
• Ensure your SMEs are aligned to the topics they are going to be asked the most
• Improve SME effectiveness by conducting thorough simulated inspection scenarios
• Satisfactorily answer questions commonly asked by investigators
• Avoid providing “extra information” that was not required to answer a question
• Successfully push back against FDA investigators' requests for documents
• Avoid angry responses, body language and tone of voice that can derail interviews
• And much more
Who Should Attend
• Compliance personnel
• Regulatory affairs professionals
• QA/QC personnel
• Potential SMEs for inspection
Conference Details:
FDA’s New Inspectorate Re-Org to Put Pressure on SMEs
**FDAnews Webinar**
Feb. 23, 2015 — 11:30 a.m. – 1:00 p.m. EST
Easy Ways to Register:
Online: www.fdanews.com/InspectorateReOrg
By phone: 888-838-5578 or 703-538-7600
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