Regulatory Authority Compliance

With more stringent compliance parameters set by the USFDA the quality assurance of pharmaceutical products is ensured. In addition to cGMP, GLP and GCP practices as per the US Federal law pharma products should comply with 21CFR regulations. Also on a regular basis the FDA organizes compliance programs for the pharma industries in program areas like Biologics (CBER), Bioresearch Monitoring (BIMO), Devices/Radiological Health (CDRH), Drugs (CDER), Food and Cosmetics (CFSAN), Veterinary Medicine (CVM). The results of regulatory audits NAI – No Action Indication, VAI – Voluntary Actions Indicated, OAI – Official FDA Action Indicated are also critical to decide by auditors in regards to compliance matters and call for several challenges to overcome by the manufacturers. 

  • Food and Drug Administration (FDA)
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Therapeutic Goods Administration (TGA)
  • Central Drug Standard Control Organization (CDSCO)
  • Health Canada
  • European Medicines Agency (EMEA)

Related Conference of Regulatory Authority Compliance

June 08-09, 2018

7th International conference on Pharmaceutical Auditing

Baltimore, Maryland, USA
June 27-28, 2018

4th International Conference on Drug Discovery, Designing and Development

Vancouver, British Columbia, Canada
August 20-21, 2018

9th Asian Biologics and Biosimilars Congress

Tokyo, Japan
October 18-19, 2018

18th World Pharma Congress

Warsaw, Poland
August 15-17, 2018

8th World Congress Spectroscopy and Analytical Techniques

Stockholm, Sweden
September 18-19, 2018

6th European Biopharma Congress

Amsterdam, Netherlands

Regulatory Authority Compliance Conference Speakers

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