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Provo, Utah
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GMP Inspection Training: How to Avoid Citations and Prepare for Your Next FDA Inspection

Event Start Date: 6/27/2017

Event End Date: 6/28/2017

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There are currently 33 spaces left.
Cost per place: $1,295.00

UNPA GMP Training:

GMP Inspection Training: How to Avoid Citations and Prepare for Your Next FDA Inspection

 

June 27-28

Provo Marriott Hotel & Conference Center

Provo, Utah

 

UNPA GMP/PCQI training is sponsored by 

 

 



View a short video by Larisa Pavlick introducing this training.

For a PDF of the program and the complete agenda click here.

Join the United Natural Products Alliance for two intensive days of GMP training that will provide exactly what you need to know before your next FDA GMP inspection or audit, with a focus on the key elements of quality: identity, purity, strength and composition. Taught by former FDA Investigator Larisa Pavlick, UNPA’s VP, Global Regulatory & Compliance, who has been in more than 200 facilities. 


This training will equip your manufacturing, operations, QA/QC, management, purchasing, regulatory and compliance personnel with all the tools and resources they’ll need to handle and respond to your FDA GMP inspections or audits.

 

What you’ll learn:

 

DAY ONE

  • The state of the industry, including trends, regulatory actions, 483 Observations and new regulations
  • Understanding the laws, regulations and guidance documents
  • A review of the FDA Establishment Inspection—section by section—and how to be prepared
  • Facilities registration

 

DAY TWO

  • Establishment Inspections (cont'd)
  • The Request for “Written Procedures”
  • Manufacturing Operations—a section by sectionreview
  • Understanding the quality control section in the Compliance Program
  • The FDA Product Review: Expectations and establishing release criteria
  • Attachment E and raw materials of special interest
  • The close-out meeting
  • Preparing a written response to an FDA 483
  • EI classifications and what to expect post-EI
  • FSMA: Are you ready?

        …and much more!

 

REGISTRATION

Reserve your seat now and save 20 percent when you book by June 5!

 

$1,295 Regular Price

$995 UNPA Member Regular Rate

 

VENUE

Provo Marriott Hotel & Conference Center

101 W 100 N, Provo, UT 84601

 

The venue hotel is nearly sold out. Please call 800.228.9290 to find out room availability.

  

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