All delegates receive an example of GMP for Medical Devices · 3 Risk Management SOP All delegates...
Transcript of All delegates receive an example of GMP for Medical Devices · 3 Risk Management SOP All delegates...
SPEAKERS:
Dr Gerhard BauerChemgineering Business Design GmbH
Harald Rentschlermdc, medical devices certification GmbH
Dr Heinrich PrinzApceth GmbH & Co. KG
HIGHLIGHTS:
� Regulatory Requirements
� Certification Procedures
� Technical Documentation
� Combination Products
� Design Controls
� Validation /Qualification
� Regulatory Audits
� CAPA and Complaint Handling
GMP for Medical DevicesTHE Overview of FDA GMP/EU Aspects for Medical Devices
1 - 2 October 2014, Heidelberg, Germany
EU versus USA
***NEW***All delegates receive an example of
a Risk Management SOP
This education course is recognised for the ECA GMP Certification Programme „Certified QA Manager“. Please find details at www.gmp-certification.eu
Also for free: � FDA Medical Device Warning Letter
Navigator on CD-ROM � Validation of Processes for Production and
Service Provision (including Software) - Essential Requirements
NEW
Objectives
The aim of the course is to identify similarities and differ-ences between the regulations of the FDA and the Euro-pean 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
3 Parallel Workshops
DocumentationHow to structure a technical documentation
FDA InspectionHow to prepare an FDA inspection
Audit findingsAssessment of audit findings – how to react?
A Notified Bodies representa-tive will start the course by ex-plaining the regulatory re-quirements. In the further presentations particular attention will be paid to findings made during FDA inspections.
3 Parallel workshops – con-centrating on technical docu-mentation, preparing an FDA inspection and audit findings – will provide practical orien-tation.
Background
Since 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 regu-lations 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 regu-late 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 Informa-tion Act. For years now, CAPA/Complaint Handling, in-sufficient Design Controls, Management Responsibility, Process Controls and Process Validation and Quality Au-dits have been among the Top 5 deviations.
Target Audience
This event has been especially designed for the manufac-turers 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.
Programme
Regulatory Requirements � European Directives � FDA � Standards � 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 Documentation
� 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 require-ments 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
GMP for Medical Devices
1 - 2 October 2014, Heidelberg, Germany
Qualification and Validation � Regulatory requirements (FDA, Standards, GHTF) � Risk assessments � Qualification � Validation � Audit and inspection findings
Audits � 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 require-ments 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
Three add-ons for free
1 FDA Medical Device Warning Letter Navigator on CD-ROMThis CD contains:
� The Medical Device-associated FDA and GHTF Guidelines in full text
� EU Medical Device Directives and MedDev Docu-ments
� A user interface that offers a full-text search � All Medical Device associated FDA Warning Letters since 2002.
2 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 understand-ing of validation of processes, including validation of software among notified bodies, manufacturers and the competent authorities, and at defining uniform require-ments on the validation of processes to be met by the manufacturers and on the auditing of these processes by notified bodies or certification authorities.
3 Risk Management SOPAll delegates receive an example of a Risk Manage-ment SOP
Social Event
On 1 October, you are cordially invited to a social event. This is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.
Speakers
Dr Gerhard BauerChemgineering Business Design GmbHDr Bauer has more than 20 years of profes-sional experience in the Life Science In-dustry. He has experience as project man-ager, Head of Controlling, Head of Procurement, external and internal con-
sulting (GMP Compliance), Audits of pharmaceuticals, medical devices, and API manufacturers in the EU, Asia, and the US. Since 2004 he is Head of the Business Unit Consulting of the Chemgineering Group.
Harald Rentschlermdc medical device certification GmbHMr Rentschler is a Biomedical Engineer and since more than 17 years performing conformity assessment activities for medi-cal devices. He is General Manager of mdc medical device certification GmbH, a No-
tified Body with broad experience in the field of medical devices and in-vitro diagnostic devices. Mr Rentschler is a member of national and international working groups in the field of medical devices and quality system certifi-cation.
Dr Heinrich PrinzApceth GmbH & Co. KG, GermanyDr Prinz worked with Boehringer Mann-heim before he joined Biotest where he was Head of Quality Assurance, responsi-ble for both the pharmaceutical and the medical device division. Since 2003 he
works as a freelance consultant and part of his time he is the Senior Supervisor ‘Production and Quality Assurance’ at Apceth, a biotech company.
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Date
Wednesday, 1 October 2014, 10.00 – 18.00 h(Registration and coffee 09.30 – 10.00 h)Thursday, 2 October 2014, 08.30 – 16.30 h
Venue
NH Hotel HeidelbergBergheimer Strasse 9169115 Heidelberg, GermanyPhone +49 (0)6221 1327 0Fax +49 (0)6221 1327 100
Fees
ECA Members € 1,490.- per delegate plus VAT APIC Members € 1,590.- per delegate plus VATNon-ECA Members € 1,690.- per delegate plus VATEU GMP Inspectorates € 845.- per delegate plus VATThe conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on the first day, lunch on both days and all refreshments. VAT is reclaimable.
Accommodation
CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation form when you have registered for the event. Reservation should be made directly with the hotel. Early reservation is recommended.
Registration
Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.
Conference Language
The official conference language will be English.
Organisation and Contact
CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, GermanyPhone ++49-62 21/84 44-0 Fax ++49-62 21/84 44 [email protected]
For questions regarding content:Mr Sven Pommeranz (Operations Director) at +49-62 21/84 44 47, or per e-mail at [email protected] questions regarding reservation, hotel, organisation etc.:Mr Ronny Strohwald (Organisation Manager) at +49-62 21/84 44 51, or per e-mail at [email protected].
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