GMP for Medical Devices

(Im Auftrag der European Compliance Academy)

GMP for Medical Devices <p>(Im Auftrag der European Compliance Academy)

Heidelberg, Germany

Seminar Nr. 9244


Die Veranstaltung hat bereits stattgefunden

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail:


Dr Gerhard Bauer, Chemgineering Business Design GmbH
Harald Rentschler, mdc, medical devices certification GmbH
Dr Heinrich Prinz, Apceth GmbH & Co. KG


The aim of the course is to identify similarities and differences between the regulations of the FDA and the European regulations for Medical Devices. The focus will be on

Certification Procedures
Technical Documentation vs Device History File and Device Master Record
Combination Products
Design Controls
Validation / Qualification
Regulatory Audits
CAPA and Complaint Handling

A Notified Bodies representative will start the course by explaining the regulatory requirements.
In the further presentations particular attention will be paid to findings made during FDA inspections.

3 Parallel workshops – concentrating on technical documentation, preparing an FDA inspection and audit findings – will provide practical orientation.


ince 1996, the requirements for the development, the manufacture and the distribution of medical devices in the USA have been laid down in the revised cGMP regulations for Medical Devices (21 CFR 820, QSR). In the USA, medical devices are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). Inspections are primarily performed by the FDA.

In Europe, three EU directives (90/385/EWG, 93/42/EWG and 98/79/EG) and one amending directives regulate the medical devices industry. GMP regulations - strictly speaking - are not notified. Instead, harmonised standards represent the state-of-the-art in the area of the EU. Inspections are primarily performed by Notified Bodies („New Approach for Product Regulations and Conformity Assessment“ ).

Statistical data about deficiencies of medical devices do only exist in the USA because of the Freedom of Information Act. For years now, CAPA/Complaint Handling, insufficient Design Controls, Management Responsibility, Process Controls and Process Validation and Quality Audits have been among the Top 5 deviations.


This event has been especially designed for the manufacturers who are subject to the medical device legislation and want to become familiar with the practice-oriented implementation of the legal requirements in the USA and in Europe.

Three add-ons for free

FDA Medical Device Warning Letter Navigator on CD-ROM
This CD contains:
The Medical Device-associated FDA and GHTF /IDMF Guidelines in full text
EU Medical Device Directives and MedDev Documents
A user interface that offers a full-text search
All Medical Device associated FDA Warning Letters since 2002.

You will also receive the document „Validation of Processes for Production and Service Provision (including Software) - Essential Requirements” developed by the Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) – English translation. This 8 page document aims at reaching a common understanding of validation of processes, including validation of software among notified bodies, manufacturers and the competent authorities, and at defining uniform requirements on the validation of processes to be met by the manufacturers and on the auditing of these processes by notified bodies or certification authorities.

Change Control SOP
All delegates receive an example of a Change Control SOP with a Change Control Flowchart and a Change Application Form.


Regulatory Requirements
European Directives
Notified Bodies

Differences between EU and FDA Requirements
European Requirements
FDA Requirements
Differences and common interests

CE and ISO Certification
Requirements of the EC/EU Directives
Use of Standards
ISO 13485 as a basic norm
Implementing a system
Certification Procedures

Technical Documentation vs. DHF/DMR
Content of Technical
Technical Documentation as a linking document
between production and quality control
Change Management – Retests
Content of the DHF
Relation to the DMR
Link to Technical Documentation
Audit and inspection findings

Combination Products
The Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products – an overview
Combination products in the EU – Guidelines and Definitions
How to classify the combination product
Conformity assessment
The consultation procedure

Design Controls
Introduction of regulatory requirements
Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
How to implement Design Controls in the whole life cycle process
Modern concepts of development of products
Audit and inspection findings

Qualification and Validation
Regulatory requirements (FDA, Standards, GHTF)
Risk assessments
Audit and inspection findings

Preparing for an Audit
Performance of an Audit
Nuts and bolts of an Audit
The Audit report

CAPA/Complaint Handling
Regulatory requirements (EU, FDA, Standards, GHTF)
Common aspects/differences regarding the requirements of the ISO 13485 and 21 CFR 820
CAPA – the motor for continuous improvement
Monitoring as a subsystem
Interface complaint handling /CAPA System
Audit and inspection findings


GMP Seminare nach Thema

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