Monday, December 10, 2012

GMP Posters & QSR Posters - Buy The Entire Collection!

Take advantage of a simple way to reinforce your compliance messages, by putting up posters.

As many trainers and managers know, creating excitement about the next training topic or  keeping the compliance message alive after training is always a challenge.

This product line of large posters, created by the well-known San Francisco artist, Francis Redman, attracts attention and reinforces key compliance messages.
  • Buy individual posters, by image or by compliance message
  • Buy all the posters on CD
Individual Posters
You can choose individual posters, by selecting an image and then selecting a compliance message.
QSR & GMP Posters by SkillsPlus International Inc.

All The Posters on CD
Better yet, purchase all the posters on CD.  This way you'll get 12 different posters and 56 different slogans to choose from.
QSR & GMP Posters on CD - the Catalog - SkillsPlus Intl Inc.
Purchase QSR & GMP Poster on CD - via the SkillsPlus Intl Inc secure site

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Tuesday, December 4, 2012

2013 Plan For FDA CDRH Guidance Documents

The CDRH is considering developing a variety of guidance documents in fiscal year 2013. Specific topics and status as final and draft guidance document, are provided in the two lists:


Prioritized medical device guidance documents that the Agency intends to publish in FY 2013 ("A-list")


Final Guidance Topics
  • Refuse to Accept (RTA) Policy for 510(k) Submissions
  • Acceptance and Filing Review for Premarket Approval Applications
  • Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies
  • In Vitro Companion Diagnostic Devices
  • Design Considerations for Pivotal Clinical Investigations for Medical Devices
  • De Novo Classification Process (Evaluation of Automatic Class III Designation)
  • The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications
  • CDRH Appeals Processes
  • Medical Device Classification Product Codes
  • The Pre-Submission Program and Meetings with FDA Staff
  • Mobile Medical Applications
  • eCopy
  • Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

Draft Guidance Topics
  • Distinguishing and Reporting Medical Device Recalls from Product Enhancements
  • Types of Communication During the Review of Medical Device Submissions
  • FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations
  • eCopy
  • Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

Device guidance documents that the Agency intends to publish, as the Agency’s guidance-development resources permit each in FY 2013 ("B-list")


Final Guidance Topics
  • Finalizing existing draft guidance documents.

Draft Guidance Topics
  • Benefit-Risk Determinations in Premarket Notifications (510(k)s)
  • Direct to Consumer (DTC) Genetic Testing: IVDs
  • Transfer of Ownership of a Premarket Notification (510(k)) - Questions and Answers
  • Custom Devices


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