gmp-trainingcourses.com 


CGMP Training Courses are available for purchase, singly or grouped, for U.S. FDA-regulated industries:
o  Medical device companies
o  Pharmaceuticals
o  Dietary supplements
o  Medical gases
o  Annual cGMP training to meet U.S. FDA    
   requirements

Some one-hour Power Point Presentations:

01. Quality System Regulation (The GMPs),  
      21 CFR Part 820; or

02. ISO 13485 (Medical Device Quality
      Management System); or

03. ISO 14971 (Product Hazard Analysis / Risk   
      Management / Files / Reports); or

04. CAPA; or

05. Risk-Based Verification and Validation
      Planning to Satisfy U.S. FDA and ISO
      13485 Requirements; or

06. Failure Investigation / Root-Cause Analysis; or

07. Software Master Validation Planning.  

 



To review GMP Training Course titles or to order, click the link below ...

Click here to review and/or order a GMP Training Course or PPT E-File.

This site  The Web 

J. E. Lincoln and Associates LLC, P O Box 2786, St. George UT 84771-2786 | Phone: 435.840.0252 | jel@jelincoln.com


Our Current Good Manufacturing Practices (CGMP) / Quality System Regulation Training Courses, On-site, webinars, workshops, DVDs for computer or televsion, provide basic training that can be used 'as-is' or added to by our or your personnel to meet your company's specialized needs.  Our staff is also available to provide custom consulting for unique requirements -- contact us for a quote. 

GMP training is available for:
  o  Medical device -- design and manufacturing;
  o  Pharmaceuticals;
  o  Medical gases;
  o  Dietary supplements / nutraceuticals;
  o  CAPA;
  o  Design Control;
  o  Validations -- DQ, IQ, OQ, PQ, software, 21 CFR Part 11;
  o  Product Risk Management Plans / Files / Reports (ISO 14971:2007);
  o  510(k)s;
  o  GMP compliance / internal audits;
  o  Others available on request.

Most of our training results have been subjected to U.S. FDA review or audit, often in response to a company's GMP remediation effort.  They include the U.S. FDA's requirements under 21 CFR 820, 111, 210, 211, ISO 13485, ISO 9001, and ISO 14971. 

Our consulting firm also specializes in training, organizational development, and executive coaching services that are tailored to your business, your challenges, and your people.

Our work is grounded in real business issues to produce tangible, bottom line outcomes. We use the context of your business to develop the strategies and behaviors necessary for success in today's market driven climate.

Click here to review and/or order a GMP Training Course or PPT E-File.


Ask the Expert!

For free email business advice, send your questions, comments or ideas to jel@jelincoln.com. For issues that are of particular interest to the the community, we may publish (with your permission) your questions along with our answers on this web site.

Click here for CGMP consulting information

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                                                                                                                                     Site last updated 02/16/2013.