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Cary, NC – In 2014, nearly 10% of 483 observations by the FDA stemmed
from issues with Master Batch Records. Improving Master Batch Records
can reduce 483s, make completing your batch records easier and
ultimately improve the quality of dietary supplements. InstantGMP teams
up with consultant Marian Boardley to share advice on writing Master
Batch Records that comply with Current Good Manufacturing Practices
(cGMP). Their webinar, Tips for GMP Compliant Master Batch Records, will take place on Tuesday, April 21st at 1 PM EST.

In addition to general advice, compliance experts will share
real incidents that illustrate common issues with Master Batch Records
and how to solve them. Other topics covered include:

  • Master Batch Record vs. Batch Production Record
  • Creating a Master Batch Record
  • What the FDA looks for in a Master Batch Record
  • Master Batch Record Checklist
  • Capturing your Manufacturing Process

“InstantGMP develops electronic batch record software that
reinforces Good Manufacturing Practices” says Dr. Richard Soltero,
President of InstantGMP.  “We find that many of our
customers struggle with writing Master Batch Records that are compliant
with GMP. We hope this seminar will help them find better ways to
approach this task.”

“Compliant master manufacturing and batch
production records are fundamental to your cGMP implementation, and they
are probably the most important documents that FDA will examine to
assess your firm’s quality system,” says Marian Boardley.  “If
you don’t include all the elements required by 21 CFR Part 111 in your
production records, you are at risk of receiving a Form 483 during your
next inspection, or even a Warning Letter.  This webinar
will discuss the most common problems actually found in dietary
supplement master manufacturing records by inspectors, and how you can
fix them.”

The cost to attend is $25 and interested parties can register
for the event via Eventbrite –


About InstantGMP

InstantGMP, Inc. develops cloud-based electronic batch record
software and SOPs that reinforce Good Manufacturing Practices. These
software systems were developed to meet standards specific to the
pharmaceutical industry and were recently updated for the Dietary
Supplement industry. Please visit the Resource Center at
for articles, videos and tutorials on GMP compliance.

About Marian Boardley

Marian Boardley
is an independent consultant who manages compliance projects for dietary
supplement manufacturers and distributors. She helps clients in the
food, drug, and dietary supplement industries to implement CGMP’s and
comply with other applicable regulations. She regularly trains staff to
be ready for FDA inspections and writes documentation, including SOP’s,
specifications, master manufacturing and batch records, for quality
control, laboratory, and manufacturing operations.

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