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Quality Agreements & FDA – What You Must Know to Comply
Joanna Gallant
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Adverse Event Reporting: Avoiding Common Pitfalls
Michael Pierro
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Reacting to “Human Error” – Moving Beyond “Retraining” As A Response
Joanna Gallant
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Aging Biotech and Aseptic Facilities – Renovation for Survival
Erich Bozenhardt, Herman Bozenhardt
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Using Social Media for Patient Recruitment in Clinical Trials
Rahlyn Gossen
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Root Cause Analysis Post ICH GCP E6 (R2): Beyond Fishbones and 5 Whys!
Sandra “SAM” Sather
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CRO Oversight: Risk Assessment & Action Planning
Sandra “SAM” Sather
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FDA Guidance on Social Media: Questions Answered and Unanswered
Dale Cooke
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Pediatric Clinical Trials: Special Considerations and Requirements
Chuck Sather
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