Prescription and Over-the-Counter GMPs: Avoiding FDA Form 483 and Making the Best Decisions

Emerging Market, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Wednesday, October 14, 2015

Prescription and OTC GMP is a system for ensuring that products are consistently produced, packaged, tested and controlled according to current, established quality standards. The GMPs are designed to minimize the risks involved in any pharmaceutical operation. The GMPs cover all aspects of production from starting materials, facilities and equipment to training and personnel hygiene.

This presentation is designed to detail the similarities and differences between GMP controls for Rx and OTC products.

Speaker

Eileen C. Nieto, CQA, Compliance Specialist, Compliance Insight, Inc.

With 25 years of diverse experience across Rx /OTC Pharmaceutical and medical device industries including clinical, API, finished product and packaging with large and small size firms, Eileen brings a wealth of knowledge to the podium. Proven expertise advancing products/ QA systems from development into commercialization and remediation of QA systems to achieve sustainable, “best in class” compliance.

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Who Should Attend?

Senior level professionals involved in Quality Assurance and Manufacturing for biopharmaceutical industry.

Xtalks Partner

Compliance Insight

Compliance Insight offers hands-on compliance, quality assurance, clinical and regulatory affairs guidance and consulting that is reliable, accurate, timely and supportive of the client’s goals and compliant with US FDA Regulations.

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