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

30 September - 01 October 2015, Heidelberg, Germany

EU versus USA

***NEW***All delegates receive an example of

a Change Control 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

wa/vers01/15102014

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

30 September - 01 October 2015, 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 /IDMF 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 Change Control SOPAll delegates receive an example of a Change Con-trol SOP with a Change Control Flowchart and a Change Application Form.

Social Event

On 30 September, 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.

Lufthansa Shuttle Bus: It leaves Frankfurt Air-port approximately every 60 minutes to the Heidelberg Crowne Plaza Hotel, which is less than 1 km away from the nH-Hotel. Info: www.lufthansa.com/de/en/Lufthansa-Airport-Bus

Airport Shuttle Service: Airport shuttle services bring you promptly and reliably from the air-port to your hotel.Info: https://www.tls-heidelberg.de/en/home/

Train: You can get on the train at the Airport Station. A train leaves up to three times per hour and it usually takes less than one hour to get to Heidelberg.

Heidelberg – Optimal Accessibility via Frankfurt:

Rese

rvat

ion

Form

(Ple

ase

com

ple

te in

full)

GM

P fo

r Med

ical

Dev

ices

, 30

Sep

tem

ber

- 0

1 Oct

ob

er 2

015

, Hei

del

ber

g, G

erm

any

Plea

se c

hoo

se O

NE

wo

rksh

op

s:

�W

ork

sho

p 1

Tech

nica

l Do

cum

enta

tion

�

Wo

rksh

op

2 A

udit

find

ings

�W

ork

sho

p 3

Pre

par

ing

an F

DA

aud

it

*

Mr.

*M

s.

Title

, firs

t nam

e, s

urna

me

Co

mp

any

Dep

artm

ent

Imp

ort

ant:

Ple

ase

ind

icat

e yo

ur c

om

pan

y’s

VA

T ID

Nu

mb

er

Purc

has

e O

rder

No

. ( if

ap

plic

able

)

Stre

et/P

.O. B

ox

City

Z

ip C

od

e C

oun

try

Pho

ne/F

ax

E-M

ail (

ple

ase

fill i

n)

Date

Wednesday, 30 September 2015, 09.30 – 18.00 h(Registration and coffee 09.00 – 09.30 h)Thursday, 1 October 2015, 08.30 – 16.30 h

Venue

NH Hotel HeidelbergBergheimer Strasse 9169115 Heidelberg, GermanyPhone +49 (0)6221 1327 0Fax +49 (0)6221 1327 100

Fees (per delegate plus VAT)

ECA Members € 1,490 APIC Members € 1,590Non-ECA Members € 1,690EU GMP Inspectorates € 845The conference fee is payable in advance after re-ceipt of invoice and includes conference docu-mentation, 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

ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERGP.O. Box 10 17 6469007 Heidelberg, GermanyPhone ++49-62 21/84 44-0 Fax ++49-62 21/84 44 34info@concept-heidelberg.dewww.concept-heidelberg.de

For questions regarding content:Mr Sven Pommeranz (Operations Director) at +49-62 21/84 44 47, or per e-mail at pommeranz@concept-heidelberg.de.For questions regarding reservation, hotel, organisation etc.:Mr Ronny Strohwald (Organisation Manager) at +49-62 21/84 44 51, or per e-mail at strohwald@concept-heidelberg.de

If th

e b

ill-t

o-a

dd

ress

dev

iate

s fr

om

the

spec

ifica

tions

on

the

right

, ple

ase

fill o

ut h

ere:

C

ON

CEP

T H

EID

ELBE

RG

P.O

. Box

1017

64

Fax

+49

(0) 6

2 21

/84

44 3

4

D

-690

07

Hei

del

ber

g

GER

MA

NY

Easy Registration

Reservation Form:CONCEPT HEIDELBERGP.O. Box 10 17 6469007 HeidelbergGermany

Reservation Form:+ 49 6221 84 44 34 @ e-mail:

info@concept-heidelberg.de Internet:www.gmp-compliance.org

wa/vers01/15102014Gen

eral

term

s an

d c

ond

itio

nsIf

you

cann

ot a

ttend

the

conf

eren

ce y

ou h

ave

two

optio

ns:

1. W

e ar

e ha

ppy

to w

elco

me

a su

bst

itute

col

leag

ue a

t any

tim

e.2.

If y

ou h

ave

to c

ance

l ent

irely

we

mus

t cha

rge

the

follo

win

g pr

oces

sing

fees

: Can

cella

tion

- un

til 2

wee

ks p

rior t

o th

e co

nfer

ence

10 %

,-

until

1 w

eeks

prio

r to

the

conf

eren

ce 5

0 %

- w

ithin

1 w

eek

prio

r to

the

conf

eren

ce 10

0 %

.C

ON

CEP

T H

EID

ELBE

RG re

serv

es th

e rig

ht to

cha

nge

the

mat

eria

ls, i

n-

stru

ctor

s, o

r spe

aker

s w

ithou

t not

ice

or to

can

cel a

n ev

ent.

If th

e ev

ent

mus

t be

canc

elle

d, r

egis

tran

ts w

ill b

e no

tified

as

soon

as

poss

ible

and

w

ill re

ceiv

e a

full

refu

nd o

f fee

s p

aid

. CO

NC

EPT

HEI

DEL

BERG

will

not

b

e re

spon

sib

le fo

r dis

coun

t airf

are

pena

lties

or o

ther

cos

ts in

curr

ed

due

to a

can

cella

tion.

Te

rms

of p

aym

ent:

Pay

able

with

out d

educ

-tio

ns w

ithin

10 d

ays

afte

r rec

eip

t of i

nvoi

ce.

Imp

ort

ant:

Thi

s is

a b

ind

ing

regi

stra

tion

and

ab

ove

fees

are

due

in

case

of c

ance

llatio

n or

non

-ap

pea

ranc

e. If

you

can

not t

ake

part

,

you

have

to in

form

us

in w

ritin

g. T

he c

ance

llatio

n fe

e w

ill th

en b

e ca

lcul

ated

acc

ord

ing

to th

e po

int o

f tim

e at

whi

ch w

e re

ceiv

e yo

ur

mes

sage

. In

case

you

do

not a

ppea

r at t

he e

vent

with

out h

avin

g in

form

ed u

s, y

ou w

ill h

ave

to p

ay th

e fu

ll re

gist

ratio

n fe

e, e

ven

if yo

u ha

ve n

ot m

ade

the

paym

ent y

et. O

nly

afte

r we

have

rece

ived

yo

ur p

aym

ent,

you

are

entit

led

to p

artic

ipat

e in

the

conf

eren

ce

(rec

eipt

of p

aym

ent w

ill n

ot b

e co

nfirm

ed)!

(As

of Ja

nuar

y 20

12)

Priv

acy

Polic

y: B

y re

gist

erin

g fo

r thi

s ev

ent,

I acc

ept t

he p

roce

ssin

g of

my

Pers

onal

Dat

a. C

once

pt H

eid

elb

erg

will

use

my

dat

a fo

r the

pr

oces

sing

of t

his

ord

er, f

or w

hich

I he

reb

y d

ecla

re to

agr

ee th

at m

y pe

rson

al d

ata

is s

tore

d a

nd p

roce

ssed

. Con

cept

Hei

del

ber

g w

ill o

nly

send

me

info

rmat

ion

in re

latio

n w

ith th

is o

rder

or s

imila

r one

s. M

y pe

rson

al d

ata

will

not

be

dis

clos

ed to

third

par

ties

(see

als

o th

e pr

i-va

cy p

olic

y at

http

://w

ww

.gm

p-co

mpl

ianc

e.or

g/ec

a_pr

ivac

y.ht

ml).

I n

ote

that

I ca

n as

k fo

r the

mod

ifica

tion,

cor

rect

ion

or d

elet

ion

of m

y d

ata

at a

ny ti

me

via

the

cont

act f

orm

on

this

web

site

.

#