GXP Academy
a division of GMP Publications, Inc.  & The Auditing Group, Inc.
 

 

GMP - GCP - GLP - Mock FDA and PAI Audit Seminars for the Regulated Industry

 About Us  |On-Site Seminars  |  Off-Site Seminars  |Register  |Brochure

On-Site Course

 Basic GMP 101
Good Manufacturing Practice

 Course Description
 2 - Day on-site all inclusive

 Applicability & Implementation

  Good Manufacturing Practice

  21 CFR Part 210/211 Drug GMPs

  Predicate Rules – Parts 11 & 820

  GMPs for the 21st. Century

  Auditing for GMPs

 

 Details | Register!
 

 Basic GLP 101
Good Laboratory Practice

 Course Description
 2 - Day on-site all inclusive

 Applicability & Implementation

  Good Laboratory Practice

  21 CFR Part 58

  Predicate Rules – Parts 11 & 820

  OECD General Principles of GLP

  Auditing for GLPs

  ISO 17025 Highlights

 

 Details | Register!
 

Electronic Systems 101
Course Description
21 CFR Part 11 Electronic Records;  Electronic Signatures including;
  Applicability
  Implementation
  Preambles
  Scope and Applications
  Systems Used In Clinicals
  Principles of Systems Validation

  EU Compliance RequirementsPart 11 Seminar

Details | Register!
 

Quality Systems (820)
Course Description

  21 CFR Part 820 QSR
  Applicability
  Implementation
  Predicate Rules Parts 11/210/211
  GMPs for the 21st. Century
  Quality Systems Approach to GMPs
  The Device Auditor's Checklist

Details | Register!
 

Good Auditing Practices
Course Description
  Auditing against the GMPs
  Auditing against Predicate Rules
  Concepts and Development
  Risk Assessment

 

Details | Register!
 

On-Site Seminars - All Inclusive On-Site 2 day seminars - $6,995.00*

You own the handbooks, now, get the training from the experts -

GMP Publications & The Auditing Group, Inc. Your Compliance Partners!   

 

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

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

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

GMP Publications
GXP News for the Regulated Industry Whats new with the FDA
Conferences and Training Seminars
GXP Recruiters - Recruiters for the BioPharmaceutical Industry
 





 

 

 

 

 

 

 


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     Download Presentation

 


GMP Publications, Inc.®

© 2001 - 2010 GMP Publications, Inc. All Rights reserved

4 Linda Lane, Southampton, NJ 08088   -   P.O. 335, Medford, NJ 08055
Phone: 866-GXPNews  (866-497-6397)  Local: 856-810-1825