SlideShare ist ein Scribd-Unternehmen logo
1 von 1
Downloaden Sie, um offline zu lesen
FDA Requirements for Device Labeling: Development,
Contents, Distribution, and Changes
This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive
knowledge on creation, approval and control of labels and labeling.
Why You Should Attend:
Your company's marketing department wants to entice customers to buy your product instead of your competitor's! A common
method is to make the labeling as eye-catching as possible. Be careful! You need to know what information can (and more
importantly) CANNOT be present on the labeling. Sometimes mislabeling and aggressive labeling can put you in to trouble.
This FDA labeling webinar will provide a comprehensive knowledge of labeling development and subsequent control. The updated
FDA requirements and expectations regarding labeling contents will be covered. We will discuss the recommended best practices
and how to follow it to assure substantial compliance. This presentation provides comprehensive knowledge of labeling
development and subsequent control. FDA requirements and expectations regarding labeling contents will be covered, as will
recommended practices to assure compliance.
Areas Covered in the seminar:
Prescription Device Labeling.
Misbranding, False Or Misleading Labeling.
Approval.
Issuance.
Label Integrity.
Label Inspection.
Contractor-Produced Labels As A Linkage With Purchasing Controls.
Retention.
When a labeling change requires a new submission.
Who will benefit:
This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and
labeling:
Regulatory Affairs management
Document Control (label generation) professionals
Design Control professionals
Quality Assurance professionals
Sales/marketing management
For more details please visit us:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701143?channel=D
OCorganic

Weitere ähnliche Inhalte

Mehr von complianceonline123

Excel spreadsheets how to ensure 21 cfr part 11 compliance
Excel spreadsheets  how to ensure 21 cfr part 11 complianceExcel spreadsheets  how to ensure 21 cfr part 11 compliance
Excel spreadsheets how to ensure 21 cfr part 11 compliancecomplianceonline123
 
Out in the open protecting your privacy in the digital age
Out in the open  protecting your privacy in the digital ageOut in the open  protecting your privacy in the digital age
Out in the open protecting your privacy in the digital agecomplianceonline123
 
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s PotentialReaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potentialcomplianceonline123
 
Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit complianceonline123
 
Aml non bank finanacial institutions
Aml non bank finanacial institutionsAml non bank finanacial institutions
Aml non bank finanacial institutionscomplianceonline123
 
Gdp how to manage documentation lifecycle
Gdp  how to manage documentation lifecycleGdp  how to manage documentation lifecycle
Gdp how to manage documentation lifecyclecomplianceonline123
 
I 9 compliance- how to avoid errors
I 9 compliance- how to avoid errorsI 9 compliance- how to avoid errors
I 9 compliance- how to avoid errorscomplianceonline123
 

Mehr von complianceonline123 (20)

Fmla ada overlap
Fmla  ada  overlapFmla  ada  overlap
Fmla ada overlap
 
Hipaa enforcement examples
Hipaa enforcement examplesHipaa enforcement examples
Hipaa enforcement examples
 
Excel spreadsheets how to ensure 21 cfr part 11 compliance
Excel spreadsheets  how to ensure 21 cfr part 11 complianceExcel spreadsheets  how to ensure 21 cfr part 11 compliance
Excel spreadsheets how to ensure 21 cfr part 11 compliance
 
Retail loss
Retail lossRetail loss
Retail loss
 
Hipaa privacy rule
Hipaa privacy ruleHipaa privacy rule
Hipaa privacy rule
 
Fda warning letters
Fda  warning lettersFda  warning letters
Fda warning letters
 
Dietary supplement
Dietary supplementDietary supplement
Dietary supplement
 
Out in the open protecting your privacy in the digital age
Out in the open  protecting your privacy in the digital ageOut in the open  protecting your privacy in the digital age
Out in the open protecting your privacy in the digital age
 
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s PotentialReaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
Reaching Clean Power Plan Goals at No Cost: Securing the Smart Grid’s Potential
 
Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit Audit Process: How to Successfully Plan Audit
Audit Process: How to Successfully Plan Audit
 
Basics of internal audit
Basics of internal auditBasics of internal audit
Basics of internal audit
 
Free trade zones
Free trade zonesFree trade zones
Free trade zones
 
Sec what you need to know
Sec what you need to knowSec what you need to know
Sec what you need to know
 
Auditing your grc programs
Auditing your grc programsAuditing your grc programs
Auditing your grc programs
 
Aml non bank finanacial institutions
Aml non bank finanacial institutionsAml non bank finanacial institutions
Aml non bank finanacial institutions
 
Gdp how to manage documentation lifecycle
Gdp  how to manage documentation lifecycleGdp  how to manage documentation lifecycle
Gdp how to manage documentation lifecycle
 
Workplace harrasment
Workplace harrasmentWorkplace harrasment
Workplace harrasment
 
Good documentation practices
Good documentation practicesGood documentation practices
Good documentation practices
 
Information security threats
Information security threatsInformation security threats
Information security threats
 
I 9 compliance- how to avoid errors
I 9 compliance- how to avoid errorsI 9 compliance- how to avoid errors
I 9 compliance- how to avoid errors
 

Fda requirements for device labeling

  • 1. FDA Requirements for Device Labeling: Development, Contents, Distribution, and Changes This training will provide a solid understanding of FDA Requirements for Device Labeling. Attendees will gain comprehensive knowledge on creation, approval and control of labels and labeling. Why You Should Attend: Your company's marketing department wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible. Be careful! You need to know what information can (and more importantly) CANNOT be present on the labeling. Sometimes mislabeling and aggressive labeling can put you in to trouble. This FDA labeling webinar will provide a comprehensive knowledge of labeling development and subsequent control. The updated FDA requirements and expectations regarding labeling contents will be covered. We will discuss the recommended best practices and how to follow it to assure substantial compliance. This presentation provides comprehensive knowledge of labeling development and subsequent control. FDA requirements and expectations regarding labeling contents will be covered, as will recommended practices to assure compliance. Areas Covered in the seminar: Prescription Device Labeling. Misbranding, False Or Misleading Labeling. Approval. Issuance. Label Integrity. Label Inspection. Contractor-Produced Labels As A Linkage With Purchasing Controls. Retention. When a labeling change requires a new submission. Who will benefit: This webinar is designed for those who perform, supervise, manage, audit, or oversee the creation, approval, control of labels and labeling: Regulatory Affairs management Document Control (label generation) professionals Design Control professionals Quality Assurance professionals Sales/marketing management For more details please visit us: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701143?channel=D OCorganic