"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars® - International courses in Medical Device development and production

Our international course program for Quality and Regulatory Affairs professionals in the Medical Device industry. Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.

In addition to the training listed below we offer inhouse training customized for your need. Read more here »

Course Calendar, Medical Device

Hover over the course title for a short description.
Click the title to open the full course description with dates, locations and pricing.

2018

Copenhagen, October 2018

9.10

Ensure access to the Chinese market - Preparing, Participating and Handling a CFDA Inspection   #5128   NEW

Copenhagen, November 2018

6.11

Validation of software for QMS process  #5121

6-8.11   

Medical Device Quality Management Systems (QMS) - Key requirements in ISO 13485, MDR and QSReg  #5314

13.11

Biological evaluation of medical devices, Part 1 - Introduction  #5130   NEW

14.11

Biological evaluation of medical devices, Part 2 - How to perform a biological evaluation  #5131   NEW

27-29.11

Valid Statistical Techniques for Medical Device and Pharmaceutical Firms  #5315

Copenhagen, December 2018

3-4.12

Procedures for performance: Ways to achieve improved performance  #5242

6-7.12

Better investigations, better corrective actions  #5243

10-11.12

Effective Design Controls, Outstanding Products  #5249

11-12.12   

Tools to improve poor personnel behaviors - within Pharma and Medical Devices  #5251   NEW

12.12

Essential Corrective Action and Preventive Action Practices  #5129   NEW

2019

January 2019, Online Webinar

14.1

Test Method Validation (TMV) Made Easy - Part 1  #5803    Webinar   NEW

21.1

Test Method Validation (TMV) Made Easy - Part 2  #5804    Webinar   NEW

Copenhagen, January 2019

22-24.1

Auditor/Lead Auditor - Pharmaceuticals and Medical Devices  #5316

Copenhagen, February 2019

5-7.2

QA/RA Leader Medical Devices - Unique training to become certified QA-RA Leader  #5317

 

Registration    

Course program by topic, Medical Device

Hover over the course title for a short description.
Click the title to open the full course description.
Auditing & Inspections

»

Auditor/Lead Auditor - Pharmaceuticals and Medical Devices  #5316

»

Ensure access to the Chinese market - Preparing, Participating and Handling a CFDA Inspection  #5128

Biocompatibility

»

Biological evaluation of medical devices, Part 1 - Introduction  #5130

»

Biological evaluation of medical devices, Part 2 - How to perform a biological evaluation  #5131

CAPA

»

Better investigations, better corrective actions  #5243

»

Effective Corrective Action and Preventive Action  #5250 (only in-house)

»

Essential Corrective Action and Preventive Action Practices  #5129

Cleanrooms, Contamination control, Cleaning & Cleaning validation

»

Contamination control in cleanrooms for Life Science production  #5223

Computers, software, electronic records and signatures

»

Validation of software for QMS process  #5121

Design Controls

»

Effective Design Controls, Outstanding Products   #5249

General GMP / QS Compliance

»

GMP/QS Updates - Important news in QA/QM, GMP and Quality Systems  #5126

»

From Training to Learning - Improving GMP Performance  #5232

»

Effective Management Controls for Medical Device Firms   #5122

»

Medical Device Quality Management Systems (QMS) - Key requirements in ISO13485, MDR and QSReg  #5314

»

Procedures for performance: Ways to achieve improved performance  #5242

»

QA/RA Leader Medical Devices - Unique training to become certified QA-RA Leader  #5317

»

Strategic communication - Develop your QA role  #5248

»

The new European regulatory landscape – MDR and IVDR - Conference  #5120

»

Tools to improve poor personnel behaviors - within Pharma and Medical Devices  #5251

Postmarket activities

»

Medical Device Postmarket Surveillance   #5123

Statistics

»

Valid Statistical Techniques for Medical Device and Pharmaceutical Firms  #5315

Complete training programs

»

Auditor/Lead Auditor Medical Devices

»

QA-RA Manager Medical Devices