Cosmetics - How Are They Regulated?

Duration: 90 Minutes
FDA regulates the pharmaceutical industry very actively through challenging and well-established regulations. However, FDA oversight of cosmetics manufacturing, sale and distribution is not as well defined. Knowing the difference between the regulation of these commodities, what FDA requires for cosmetics compliance, and how FDA determines that a cosmetic product has "crossed the line" into pharmaceuticals helps reduce the risk of an FDA enforcement action.
FDA Regulations for Cosmetics
Instructor: Larry Spears
Product ID: 500783

Why Should you Attend:
Participate in this webinar to understand FDA's regulations and guidance and how they are applied to the cosmetics industry. While this class is specifically designed to deal with FDA regulatory oversight and management, attendees from other countries will also benefit as the principles discussed here are consistent with those applied by regulatory authorities outside the US.

Objectives of the Presentation:
The objectives of the presentation are to speak about:
  • FDA enforcement of cosmetics and pharmaceutical regulations
  • How FDA works with industry association(s) to ensure cosmetic safety and quality
  • Do's and Don'ts in product labeling and advertising
  • Interface of Good Manufacturing Practice (GMP) with Good Distribution Practice (GDP)
  • Product traceability
  • Importance of good documentation practices
  • How cosmetics are reviewed/approved for use in the US.
  • Role of States in regulating cosmetics
Who can Benefit:
Business Owners, senior managers/managers and leaders in:
  • Quality Assurance
  • Production/Operations
  • Product Development
  • Regulatory Affairs
  • Marketing/Advertising
  • Labeling
  • Vendor Management
  • Document Control
$375
Recorded Session for one participant
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  $500.00 Training CD
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Larry Spears is currently an independent consultant and President of L.Spears Consulting, LLC, where he provides regulatory and compliance advice to medical device and pharmaceutical firms in meeting FDA requirements. He also served for over two years as a Director in Deloitte & Touche LLP's Health Sciences practice. Prior to joining Deloitte, he had 34 years of experience with the Food and Drug Administration (FDA) as an investigator, compliance officer, compliance manager and director. Larry's most recent assignment at FDA was the Deputy Director of the Office of Compliance, Center for Devices and Radiological Health, where he gained considerable experience in inspection outcome assessment, regulatory case management , and recall evaluation and classification. He also has extensive knowledge and experience in the application of FDA law, regulations, compliance and enforcement programs, policy, and strategy.

As an independent consultant and while at Deloitte, Larry has used his FDA insights and experience to assist clients in developing quality and risk strategies through the performance of activities such as: remediation of FDA Warning Letters and FDA 483s, mock inspections, process validation and contract manufacturing support, PMA inspection preparation, adverse event reporting direction, and overall regulatory governance.
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