Journal of Developing Drugs
Open Access

Joint Event on 8^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs and IPR & 8^th International Conference and Exhibition on Pharma Audit, GMP, GCP & Quality Control

June 08-09, 2018 | Philadelphia, USA

Keynote

• A blueprint for outsourcing audits of approved GxP validations

  Michael D Spangler

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• Quality management and quality audit according to GxP/GMP requirements

  Eleonora Babayants

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• A personal history of regulatory submissions technology

  Joel Finkle

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• Pharma regulatory affairs as well as importance of ISO 9001:2015, ISO 14001:2004, ISO 18001:2007 standards and related audits for quality pharma products

  Manavalan R

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• Investigations, root cause analysis, corrective & preventive actions and why human error is not the true root of the problem

  Joe Helmstetler

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• Good manufacturing practices for sterile pharmaceutical products

  Rashid Mahmood

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