FDAnews Announces — Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, Enforcement Webinar, July 11, 2019, 2019

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Don’t get a violation. Discuss the latest guidance, compliance and enforcement activities affecting compounders. It’s time for a fresh look.

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WCG Market Intelligence & Insights

Pharmacy Compounding Regulation
A Fresh Look at Guidance, Compliance, Enforcement
**An FDAnews Webinar**
Thursday, July 11, 2019 · 1:30 p.m. - 3:00 p.m. EDT
https://www.fdanews.com/pharmacycompoundingregulation0719

FDA scrutiny on compounding pharmacies is increasing

Recent example: Triad Rx, where the agency found 11 adulteration violations including visibly dirty surfaces and non-sterile cleaning methods in ISO 5 areas.

Last October Karla Palmer Esq. delivered a hard-hitting webinar on the state of compounding regulation. It’s time for an update.

Tune in Thursday, July 11, when Ms. Palmer, among the Washington FDA bar’s foremost experts on compounding, explains the 2018 Compounding Priorities Plan and shows what’s behind the accelerating enforcement. Attendees will discover:

  • Secs. 503A and 503B: How these sections of the 2013 Drug Quality and Security Act (the “Compounding Quality Act”) affect compounding pharmacies and outsourcing facilities
  • Draft and final guidances: Changes brought about in draft and final guidances to Secs. 503A and 503B
  • Warning letters and 483s: Understand what enforcement actions FDA has taken against compounders to date and what could lie down the road
  • Compounding inspections: What the FDA is looking for right now
  • Role of the states: Interplay between FDA and state regulation of outsourcing facilities and compounding pharmacies

There’s a new director of the Division of Compounded Drugs. This webinar is a must-attend even if one caught Ms. Palmer’s first presentation last October.

Interested in registering multiple sites?
Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

Webinar Details:
Pharmacy Compounding Regulation
A Fresh Look at Guidance, Compliance, Enforcement
**An FDAnews Webinar**
Thursday, July 11, 2019 · 1:30 p.m. - 3:00 p.m. EDT
https://www.fdanews.com/pharmacycompoundingregulation0719

Tuition:
$287 per site

Easy Ways to Register:
Online: https://www.fdanews.com/pharmacycompoundingregulation0719
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
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