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FDA Modern Quality Systems

Current FDA expectations for biotechnology, pharmaceutical and medical device compliance with the cGMPs for the 21st Century initiative and the International Conference on Harmonization (ICH).

 

This 14-page report details FDA recommendations from 6 officials on:

• What the FDA's new attitude toward ICH means

• EU's new annual compliance letter certification

• New emphases in the revised EU GMP Directives

• Top three investigator expectations to assess your level of intent to comply

• Two components crucial to proving compliance

• Updated rules for handling your internal audits and FDA investigators

• Updated expectations for CAPAs, risk management and annual reviews

Download a sample page.  (PDF, 92kb)

 

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Price: $79 (USD)

Contents

• Impact of ICH on FDA regulations

• Quality systems integration expectations

• Knowledge management as part of quality system

• GMP compliance and Quality by Design

• EU GMP revisions and the FDA

• EU compliance letter and FDA expectations

• Proving your intent to comply to the auditor

• Electronic record integrity

• Risk management expectations

• Internal audits and FDA inspectors

• Corrective and preventative actions (CAPA) guidance

• Recommendations for overseeing contract organizations

• Annual quality systems review guidance

 

Additional Details

This report can be purchased, downloaded, viewed and printed at your convenience.  Once you place your order, you will be given access to the report.

 

The purchase price for the report is $79 (USD).  We accept MasterCard, Visa, Discover, and American Express through PayPal for payment of the report fee.

 

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