FDAnews Announces — Responding to Compounding Pharmacy Inspections Webinar, Jan. 25, 2017

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Recently, the FDA issued 3 draft guidances governing the compounding of drugs. All three guidances emphasize that all products manufactured by outsourcing facilities must comply with GMP rules or be deemed in violation.

Responding to Compounding Pharmacy Inspections
**An FDAnews Webinar**
Jan. 25, 2016 — 1:30 p.m. – 3:00 p.m. ET
Responding to Compounding Pharmacy Inspections        

Recently, the FDA issued 3 draft guidances governing the compounding of drugs.

These guidances addressed multiple facets including: what constitutes a large-scale compounding facility…associated GMP requirements…standards for hospital compounding…and requirements for compounding without a prescription.

All three guidances emphasize that all products manufactured by outsourcing facilities must comply with GMP rules or be deemed in violation.

This 90-minute webinar will:

  • Identify the latest areas of FDA enforcement in compounding pharmacies
  • Compare requirements of 503A (traditional compounder) and 503B (outsourcing facility)
  • Review USP 797 vs. GMP requirements
  • Identify the constitution of the core FDA Inspection Team
  • Create the outline of an appropriate FDA response

Register today and be informed about compounding facility inspections.

Meet the Presenter:
Darshan Kulkarni of the Kulkarni Law Firm is a leading expert on strategic regulatory and pharmaceutical counseling.
With a background in both the law and hands-on healthcare experience (over 10 years as a pharmacist, including participation as a clinician in clinical trials), Mr. Kulkarni is versed in the needs of international device, pharmaceutical and biopharmaceutical companies and their service providers, including contract manufacturing organizations and contract research organizations.

Who Will Benefit:

  • Pharmacists
  • Compliance officers
  • Quality Managers
  • Regulatory Affairs
  • General/corporate counsel
  • Executive management
  • Quality assurance
  • Risk management specialists
  • Outside attorneys
  • Regulatory/legislative affairs professionals
  • Department supervisors/directors

Webinar Details:
Responding to Compounding Pharmacy Inspections
**An FDAnews Webinar**
Jan. 25, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/compoundingpharmacyinspections        

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/compoundingpharmacyinspections                            
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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