Preventing a poor FDA inspection will save you time, money, and most of all – the reputation of
your company and employees.  It will also provide you the opportunity to make a positive,
long-lasting impression with the FDA as well as improve your quality systems.

Avoiding 483s and Warning Letters will avoid the delay of new products, product recalls and multi-million dollar fees.  Even if you are facing 483s currently, knowing how to effectively respond will minimize your damage.
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Using the principles in Best Practices – FDA Inspections will allow
you to work more efficiently while keeping your budget
under control.

Recognizing the concepts in this educationally-charged package
will help you comply with the new FDA GMP initiative through:

• A list of mandatory and optional systems – defined by FDA
• A list of recommended procedures for each system – defined by FDA
• Comparisons between conventional and science- & risk-based system inspections
• Preparation, conduct and follow-up SOPs for risk-based inspections
• Risk assessment SOPs
• FDA interpretations for risk-based inspections
• Definitions and guidance for Risk Assessments in the on-line update section

Priced at $349.00, which includes shipping/handling, this economical package provides
the equivalent of more than 1,000 pages of fact-filled information.  Plus, you will receive
FREE on-line updates for TWO YEARS.  For a full listing of its contents, click here.

The comprehensive workbook is a single source covering all aspects of FDA inspections. It
is written by a single author who has more than fifteen years of practical, international industry experience who fully understands FDA compliance issues. To view a listing of some of
the questions answered and to learn more about the author, click here.

Why go through the hassle of reading several books, publications and internet sites
encompassing redundant information. This package includes everything you need for
prompt and efficient implementation. Advanced information like this will help you
effectively prepare your organization for your next inspection.  Click here to order on-line.