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Internal Auditor (QS Regulation 21 CFR Part 820 & ISO 13485:2003) Print E-mail
Background
Many medical device companies have trained auditors in only their general company procedure for auditing, and possibly a lead auditor course which does not encompass the importance of good understanding and interpretation of the GMP’s contained in ISO 13485:2003 and the QS Regulation 21 CFR Part 820. Consequently many audit programmes are not working effectively in ensuring the quality system is adequately complying with the GMP requirements contained in these regulations, and this leads to unsatisfactory inspection results by both Notified Bodies and FDA.
This two-day course, is designed for those with a knowledge of medical device manufacturing and intend to perform auditing activities. It starts with a review of ISO 13485:2003 and the QS Regulation 21 CFR Part 820, to ensure an in depth understanding of both regulations, including similarities and important differences.

Learning Objectives
The course provides an excellent opportunity to

  • Understand and Interpret all clauses of ISO 13485:2003 and the QS Regulation 21 CFR Part 820
  • Understand the differences between ISO 13485:2003 and the QS Regulation 21 CFR Part 820
  • Apply principles of ISO 14969
  • Apply principles of ISO 19011:2002 in the auditing process
  • Apply principles of QSIT (FDA Quality System Inspection Technique)
  • Be aware of GHTF audit guidelines
  • Plan, conduct, and report effective internal audits to senior management.

Course Format
The course presents the GMP requirements and various guidance’s comprehensively, uses case studies and interactive sessions as well as formal presentations. Each delegate is provided with a course manual containing comprehensive notes on topics presented, and copies of relevant regulations and guidance documents are provided for the use of delegates during the course. 
Delegates receive a "Certificate of Attendance".
This course can also be tailored to meet your specific requirements e.g. focus only on the QS Regulation 21 CFR Part 820, or provided as a 1 day course but this excludes the case studies.
Contact us for detailed training agenda and prices
 

Latest News

Regulatory Updates

Two new guidance documents on Clinical Investigation: MEDDEVs 2.73/3 & 2.7/4

14-12-2010

FDA CDER (&CBER & CVM) Guidance for Industry: Process Validation: General Principles and Practices

24-11-2011

FDA CDRH: Medical Device Innovation Initiative

February 2011
 
Our 2010 Success

Although the 2010  economy was a difficult year for many businesses, we can look back with justified pride in our success and draw confidence that we can improve and grow our services to the health care industry in 2011, nationally and internationally.

Here are some brief statistics on our 2010 activities, which are indicative of our ongoing success

  • we provided major services to more than 24 medical device and drug facilities
  • we agreed service contracts with 12 new companies
  • we trained over 250 people in the industry, including Competent Authority personnel
  • we successfully project managed 3 FDA compliance inspections in the UK and China
 
Smithers UK (formally RAPRA) partners with Medicom
Medicom has successfully renewed its contract for 2011 with iSmithers to provide bespoke training for medical device polymer suppliers
 
DS Certificering A/S partners with Medicom
Medicom successfully renews contract for 2011 with DS Certificering A/S to provide public and in-house medical device training courses in Denmark.

Public Training Courses

Book now to secure your place on our remaining public training courses in 2011 Dates to be announced soon

Process Validation
Device Design
QS Regulation

Book now to secure your place on our remaining public training courses in 2011 at iSmithers, UK.

Medical Device Legislation and Material Selection

14-15 June

Shawbury, Shropshire, UK.

15-16 November

Shawbury, Shropshire, UK.

Book now to secure your place on our remaining public training courses in 2011 at DS Certificering, Copenhagen, Denmark.

Process Validation

3 May
Copenhagen, Denmark

Medical Device Design and Development Control

4 May
Copenhagen, Denmark

Establishing Compliance With ISO 11135-1:2007 for Validation of Ethylene Oxide Sterilization

5 May
Copenhagen, Denmark

 

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