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

Compliance Seminars®

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

This course gives you the opportunity to share updates and news related to the requirements of GMP and quality systems (ISO 13485 and 21CFR820) within both the EU and US.

The course includes general briefings in both areas and more specific updates related to pharmaceutical GMP demands and to quality system demands for medical devices, respectively.


Course is aimed at:

  • Individuals working with audit / self-inspection and audit of suppliers
  • Supervisors / managers in production, quality, regulatory or product development
  • Process engineers, quality engineers, quality assurance and process developers
who need to stay current with regulatory requirements.
 

Course content:

During the course, topics that are trending, have news value, or where additional focus is based on both the needs of industry and public authorities priorities, are being presented and discussed.

General, common blocks are alternated with industry-specific blocks (drugs and medical devices), and these specific blocks are in parallel sessions. During the training, group exercises with a focus on sharing knowledge and experience will also be conducted.

Course objectives:

After the course you should have gained new knowledge about the latest trends and updates within GMP and quality system areas.

The course will fulfil the expectations of continuous training and professional development for auditors and other key personnel.

 

Gate2GMP®

When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
Watch this short video to learn more about what Gate2GMP® offers »

 

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Course facts

Course no:
5126
Industry:
Pharmaceuticals and Medical Device

Level:
Intermediate
GMP region:
EU and US

Language:
English

Instructors:
Anna Lundén  Åsa Runnäs
Anna Lundén, Key2Compliance AB
Åsa Runnäs, Symbioteq Kvalitet AB

Date, location and venue:

This course is only offered in-house.
Click here for more info and inquiry form »


Time:
1 day

Price (excl. local VAT):
Contact us for offer »