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GMP Publications, Inc.

Food & Drug Administration (FDA)
U.S. FDA Code of Federal Regulations & EU ICH Handbooks
Tel: 856-810-7331  Fax: 856-810-7339   
sales@gmppublications.com
 

All U.S. FDA CFR handbooks updated as of April 1st. 2010 - NOW SHIPPING!

 Stay up to date CFR rule changes  -  Email:     

CFR Rule Changes by GXPNews

Just Released July 8, 2010 Federal Register: FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs 

Featured Handbooks - US - EU - Japan GMPs   |   Part 11 Electronic Systems   |  ICH Q7 - Q8 - Q9 & Q10  |   The Auditor's Master Checklist

NEW - US - Canadian and ICH GMP Guidelines!

     

GXP ACADEMY
GXP Academy
a division of GMP Publications, Inc.
P.O. Box 335, Medford, NJ 08055
http://www.gxpacademy.com
info@gxpacademy.com
866-gxpnews (866) - 497-6397
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You own the handbooks, now, get the training from the experts - GMP Publications & The Auditing Group, Inc.

Your Compliance Partners! - All Inclusive $6,995.00*

*Includes travel, hotel, and expenses with 45 days notice.

Presentation

 

The cost of on-going GXP Training and HR Management, not including the numerous man-hours committed to the complex on-going training process has companies scrambling for resources.

GMP Publications, Inc. the leader in GMP Compliance Regulations has teamed up with The Auditing Group, Inc.  in providing GXP on-site training, resource materials, capabilities and development for companies of every size.

The Partnership builds upon GMP Publications understanding of Global Regulations and The Auditing Group’s in-the-field experience and knowledge.

The new partnership ‘GXP Academy’ is committed to your company’s training success.

Compliance is more than owning a copy of the regulations.
It is imperative that employees understand the applicability and know how to conduct business in accordance with the GXPs in accordance with the regulations.

Each employee receives the copies of the regulations; however, understanding the applicability to employee’s day-to-day job is difficult and sometimes confusing.

GMP Publications, Inc. understands the global regulations and offers up-to-date solutions and creative ways of delivery along with detailed common sense approaches to training and develop.

GXP Academy offers pre-defined and customized courses to suite all industries and disciplines under various regulation requirements

 

Courses are conducted on-site for up to 20 employees.  Additional attendees are available at an extra cost of $150.00 per attendee.


All courses include;

  • Course Material Binders for each employee with Certificate of completion

  • Mini-Regulation Handbooks for each attendee specific to training course

 

 

Basic GMP 101 - w/ Predicates
  • 2 - Day on-site all inclusive
  • Applicability & Implementation
  • Good Manufacturing Practice
  • 21 CFR Part 210/211
    Predicate Rules – Parts 11 & 820
  • GMPs for the 21st. Century – A risk based approach
  • Auditing for GMPs

Details...

Electronic Compliance 101 - Part 11
21 CFR Part 11 Electronic Records; Electronic Signatures including;
  • Applicability & Implementation
  • Preambles
  • Scope and Applications (Aug. 2003)
  • Computerized Systems Used In Clinical Investigations (May 2007)
  • General Principle of Computer Systems Validation

Details...

Quality Systems Regulations 101
  • 21 CFR Part 820 QSR
  • Applicability & Implementation
  • Predicate Rules – Parts 11 & 210/211
  • GMPs for the 21st. Century – A risk based approach
  • Quality Systems Approach to the GMPs

Details...

Good Auditing Practices 101
  • Auditing against the GMPs
  • Auditing against the Predicate Rules
  • Concepts and Development
  • Risk Assessment

Details...

     
 

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GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331   sales@gmppublications.com
Copyright©1998 - 2010 GMP Publications, Inc., FDA.COM and GXPNews
For technical assistance contact John Cuspilich, RA/QA GMP Publications, For sales & Marketing contact Michael Van Horn.
GMP Publications, Inc. P.O. Box 335, Medford, NJ 08055   856-810-7331  
sales@gmppublications.com