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Effective Compliance Solutions - GCP, GLP and GMP training and consulting services.
Effective Compliance Solutions - GCP, GLP and GMP training and consulting services.

16 followers
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Process Validation Guidance Requirements

October 22-23 2018
San Diego, CA
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China & Pacific Rim Markets : Compliance Processes for Life Science Products - Company Establishment, Clinical Trials, Registrations, Renewals and Supply Chain Considerations

August 23-24 2018
Philadelphia, PA
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GMP Expectations for Phase I Clinical Trials Training

August 21-22 2018
San Francisco, CA
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Quality Control Laboratory Compliance Training Seminar

August 30-31 2018
Philadelphia, PA
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)
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ICH E6 (R2) GCP Guidelines Issued for Review
A new draft of the ICH GCP guideline has been modified  to address the following: data integrity electronic records and controls validation of computer systems used for GCP risk management approach on behalf of the sponsor and the CRO to evaluate, identify,...
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FDA Guidance on Analytical Procedures and Methods Validation for Drugs and Biologics
The U.S. Food and Drug Administration released a final guidance on Analytical Procedures and Methods Validation for Drugs and Biologics.  The guidance document provides recommendations for submitting analytical procedures and methods validation data to supp...
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