FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.

Why Should You Attend:

If you are looking for expert guidance on regulations governing human cells, tissues and cellular and tissue-based products (HCT/Ps), this webinar will present an exclusive summary of current regulations and also detail tips to stay compliant and avoid FDA warning letters during audits.

This webinar will also:

Summarize existing rules

Enumerate common complaints from FDA

Discuss ways in which companies have tried to comply

Who Will Benefit:

Those involved in HCT/Ps should be aware of FDA’s increased scrutiny regarding manufacturers in terms of increased audits, untitled letters, and product recalls. The individuals who will benefit from this webinar include:

Managers and owners of HCT/P marketing companies

Regulatory and quality professionals working in HCT/P manufacturing sites

Employees in hospital and clinics using HCT/Ps

Instructor Profile:

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the regulatory affairs and quality assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD.

Note:

Use coupon code 232082 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-requirements-to-regulate-human-cells-tissues-cellular-and-tissue-based-products-webinar-training-703652-prdw?channel=sciencedz