FDA plans to use ISO 13485 for medical devices regulation - ISO.org

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Read the full news article: FDA plans to use ISO 13485 for medical devices regulation - ISO.org

"The announcement by the FDA that it will use ISO 13485 in replacing its current quality system regulation, is an important next step in the recognition this standard has already gained globally. 

ISO/TC 210 warmly welcomes the FDA’s planned adoption. This ISO technical committee, responsible for the quality management and corresponding general aspects for medical devices, is run by ANSI, ISO’s member in the United States."

Learn more about the proposed rule:

• RIN: 0910-AH99 - Title: Harmonizing and Modernizing Regulation of Medical Device Quality Systems
• Follow the status of the proposed rule on FDA.org (enter "0910-AH99" in the Search box)

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RAPS Releases Results of Compensation Survey of Regulatory Professionals - RAPS.org

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Read the full news article:  RAPS Releases Results of Compensation Survey of Regulatory Professionals - RAPS.org

"RAPS today released the results of its comprehensive global survey of healthcare product regulatory professionals, offering a detailed look at how much they earn, which products they work on, what their work entails, and how their roles within their organizations have evolved."

Navigate to the report:   2018 Global Compensation & Scope of Practice Report for the Regulatory Profession


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SkillsPlus Intl Inc. - The Best GMP Training & cGMP Training Around
Free GMP Training Tips
Root Cause Analysis - GMP Training
Deviation Investigation Report Writing - GMP Training
Qualstar Simulation - Advanced GMP Training That's Fun!

 

FDA Released 3 DSCSA-Related Guidances - Healthcare Packaging

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Read the full article:   ICYMI: FDA Released Three DSCSA-Related Guidances - Healthcare Packaging

According to the article, the FDA released the following guidances:

1. Product Identifiers Under the Drug Supply Chain Security Act- Questions and Answers Guidance for Industry (PDF)
2. Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier (PDF)
3. Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy (PDF)

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For Designated Representative license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training affidavit):

• CA Designated Representative Wholesaler Training - Available around-the-clock 24 x 7
• CA Designated Representative 3PL Training
• CA Designated Representative Reverse Distributor Training - New!
• The Designated Representative Institute

     Florida:

• Florida Certified Designated Representative - CDR Laws and Rules Examination Prep Course

For HMDR Exemptee license applicants  -  Training programs, courses, classes, seminars:

     California (earn a training completion certificate):

• CA Home Medical Device Retailer (HMDR) Exemptee Training Course
• The Exemptee Institute