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1.

Books : Convicted in Borison case, Diamond urges monitors to follow GCPs. (Fraud and misconduct).(Medical College of Georgia, clinical research fraud): An article from: Bioresearch Monitoring Alert

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Convicted in Borison case, Diamond urges monitors to follow GCPs. (Fraud and misconduct).(Medical College of Georgia, clinical research fraud): An article from: Bioresearch Monitoring Alert
by: Elisa Ludwig
July 31, 2005

2.

Books : FDA going to greater lengths in overseeing lyophilization, expert says.(Manufacturing): An article from: Validation Times

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FDA going to greater lengths in overseeing lyophilization, expert says.(Manufacturing): An article from: Validation Times
by: Elisa Ludwig
August 01, 2005

3.

Books : Judy Blume (Who Wrote That?)

Amazon.com's Price: $30.00

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Judy Blume (Who Wrote That?)
by: Elisa Ludwig
2003-12

4.

Books : Final FDA safety regulations may flood IRBs and, sponsors, do little for 'risk management'.(Safety reporting): An article from: Bioresearch Monitoring Alert

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Final FDA safety regulations may flood IRBs and, sponsors, do little for 'risk management'.(Safety reporting): An article from: Bioresearch Monitoring Alert
by: Elisa Ludwig, Ken Reid
July 31, 2005

5.

Books : FDA inspectors disclose means of doing BiMo audits, suspect too good documentation. (BiMo inspections).: An article from: Bioresearch Monitoring Alert

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FDA inspectors disclose means of doing BiMo audits, suspect too good documentation. (BiMo inspections).: An article from: Bioresearch Monitoring Alert
by: Elisa Ludwig
July 31, 2005

6.

Books : USP to address TOC for PAT.(Water systems): An article from: Validation Times

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USP to address TOC for PAT.(Water systems): An article from: Validation Times
by: Elisa Ludwig
August 01, 2005

7.

Books : Potential for failure should still guide Part 11 concerns with network infrastructure. (Electronic records/signatures).: An article from: Validation Times

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Potential for failure should still guide Part 11 concerns with network infrastructure. (Electronic records/signatures).: An article from: Validation Times
by: Elisa Ludwig
June 01, 2005

8.

Books : 'Quality by design,' predicting failures seen obviating stability-related recalls, NDA/ANDA holds.(Stability): An article from: Validation Times

Amazon.com's Price: $5.95

Prices subject to change.

'Quality by design,' predicting failures seen obviating stability-related recalls, NDA/ANDA holds.(Stability): An article from: Validation Times
by: Elisa Ludwig
August 01, 2005

9.

Books : 'Excursions' become hot topic in stability programs, should be written in validation plans.(Stability): An article from: Validation Times

Amazon.com's Price: $5.95

Prices subject to change.

'Excursions' become hot topic in stability programs, should be written in validation plans.(Stability): An article from: Validation Times
by: Elisa Ludwig
August 01, 2005

10.

Books : Privacy board suggested despite proposed HIPAA rule changes.(Health Insurance Portability and Accountability Act )(Brief Article): An article from: Bioresearch Monitoring Alert

Amazon.com's Price: $5.95

Prices subject to change.

Privacy board suggested despite proposed HIPAA rule changes.(Health Insurance Portability and Accountability Act )(Brief Article): An article from: Bioresearch Monitoring Alert
by: Elisa Ludwig
July 30, 2005

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