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
- Offer practical solutions to stay compliant
Areas Covered in the Webinar:
- Current regulations for HCT/Ps and review of 21CFR 1271
- GMP and GTP for HCT/Ps
- Procedures for registration and listing
- Common FDA audit findings for HCT/P manufacturing sites
- Best practices for addressing audit findings and negotiations with FDA
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
- Regulatory, compliance and quality professionals consulting with HCT/P companies
- Medical insurance and reimbursement professionals
- Physicians and consumers using HCT/Ps
Course Content
- Provide an overview for preclinical and clinical development phase for HCT/Ps
- Discuss fundamentals of HCT/Ps development and regulatory requirements
- Provide an overview for FDA’s regulatory approvals process for HCT/Ps
- Discuss FDA guidance documents and most recent policies updates for regenerative medicine and stem cell technologies
- Applicable good manufacturing and good laboratory practices
- Product labeling, marketing and advertising
- Discuss post-licensure requirements
Speaker
Mukesh KumarCourse Provider
Mukesh Kumar,