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Home
Agenda
Speakers
Venue
Accommodation
Travel
Contact
Registration




SWISSMEDIC GMP TRAINING FOR SWISS INSPECTORS 2024

Inspection of electronic systems: data integrity and validation
Outlook on new developments incl. revision of Annex 11 and AI

14-16 May 2024, Locarno, Switzerland




The international part of the Swissmedic Inspectors Training 2024 is fully
booked. The maximum number of possible participants has already been reached.
Participation on Thursday, the training day for Swiss inspectors, is still
possible. If you are interested, please send an email to
nicole.luethi@swissmedic.ch


On the first two days the event will concentrate on Inspection of electronic
systems. We are focussing primarily on the challenges of data integrity and
validation, Outlook on new developments inclusive revision of Annex 11 and AI.


Experts from the authorities and industry will give presentations on the
following topics:

 * Current and future regulatory requirements: Annex 11, comparison to CFR21
   Part 11

 * How to inspect computer system validation

 * How to inspect data integrity: Archiving/cloud, access rights, electronic
   signatures, audit trails

 * Validation of AI

 * Inspecting automated process for potential gaps




In the following Workshops with case studies, we will have the opportunity to
apply what we have learnt, discuss possible solutions together and exchange
experiences:

 * Data integrity in GMP Manufacturing

 * Performing on-site inspection regarding computerized system

 * Computer System Validation
   
   
   
   

The 3rd day is for Swiss Inspectors only and will focus on the needs of the
Swiss Inspectorates.

We are still working on the agenda for the 3rd day.



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General Information:

 * Venue: Hotel Belvedere, Locarno, Switzerland

 * Dates: 14 to 16 May 2024 (meeting starts on Tuesday 14 May, 9:30 and will end
   on Thursday, 16 May, after lunch)

 * Registration fee: There will be no registration fee. Lunches and coffee
   breaks during the training are part of the event and will be provided by
   Swissmedic.

 * Costs for travel and accommodation are on each participants own charge.



Take advantage of the Swissmedic GMP Training for Inspectors to continue your
education and to exchange experiences with other inspectors. A first draft of
the agenda is available here. As well as details of the conference venue.

We look forward to interesting and informative days at the Swissmedic GMP
Training for Inspectors 2024!


AGENDA

May 14
May 15
May 16

09:00
GMP Training for Swiss Inspectors

On the 3rd day we will focus on the needs of the Swiss Inspectorates.

The program is currently being developed.


09:00
Registration and welcome coffee


09:30
Welcome Address

Federico Cimini
09:40
Introduction of the topic

Barbara Herzog
09:45
Annex 11: Current and future regulatory requirements

Ib Alstrup
10:30
Introduction of inspection into CSV

Selecting and reviewing qualification documentation

Ib Alstrup
11:00
Coffee Break


11:30
How to inspect computer system validation

Peter Baker
12:30
Lunch Break





14:00
How to inspect data integrity

 * Archiving/cloud

 * access rights

 * electronic signatures

 * audit trails

Peter Baker
15:30
Coffee Break


16:00
Validation of AI/MI in Pharma

Stefan Münch
17:00
How to inspect AI/MI algorithms in critical applications

Ib Alstrup
17:30
End of the official part of day 1


19:00
Get together

Meeting point at the Hotel America on the Piazza Grande for an aperitif


19:30
Dinner

Ticino evening in the Caverna degli Dei, in the Hotel America on the Piazza
Grande in Locarno




SPEAKERS

Federico Cimini
Swissmedic

Barbara Herzog
Swissmedic

Barbara Herzog is a GMP/GDP Inspector and licence reviewer at Swissmedic since
2018. Before she worked for more than 20 years in the pharmaceutical industry in
various positions in Quality Assurance, Quality Control, Production, Development
and CMC projects. She gained her experience in R&D as well as in Contract
Manufacturing Organizations in early and late phase, as well as in commercial
projects in many different dosage forms. Barbara holds a PhD in pharmacy from
the University of Berne.

Ib Alstrup
DKMA Danish Medicines Agency

Peter Baker
Live Oak Quality Assurance

Stefan Münch
Körber Pharma

Stefan Münch is Vice President Validation & Qualification, responsible for the
validation and qualification services of Körber Pharma Consulting. He studied
computer science and has more than 25 years of experience in SW development
(MES) and as a consultant for the pharmaceutical industry, supporting
organizations in their agile and digital transformation.

In addition, Mr. Münch is a speaker, moderator, instructor, and author for a
variety of topics including CSV, CSA, Pharma 4.0™, digitalization, QRM, AI/ML,
SW development, cloud computing, and data integrity. He is a member of ISPE,
PDA, and GAMP D-A-CH steering committee.

Hirofumi Suzuki
PMDA Pharmaceuticals and Medical Devices Agency Japan



REGISTRATION


Deadline for registration is 1 March 2024 or as soon as the Inspectors Training
is fully booked.

The maximum number of participants has been reached. Unfortunately, we cannot
accept any more registrations.




VENUE

Hotel Belvedere

Via ai Monti 44
6600 Locarno, Switzerland

http://www.belvedere-locarno.com/
info@belvedere-locarno.com

Phone +41 91 751 03 63





ACCOMMODATION

The Ticino is a much-loved tourist destination in Switzerland. Hotel
accommodation tends to be expensive and the month of May is very popular. For
this reason, we have pre-booked rooms in various hotels for the GMP training
participants. We have tried to take into account the limited budgets of some of
the authorities.

The hotel rooms are available until 8 April 2024. After this date, all hotel
rooms will expire and Swissmedic has no longer the possibility to organise
accommodation.



Booking process

 * Hotel rooms must be booked before 8 April 2024.

 * All participants are responsible for making their own bookings.

 * Rooms are allocated on a first come first serve basis.

 * Costs for accommodation are at participants own charge.

 * Bookings are made by the participants directly with the desired hotel. Please
   write an e-mail to the hotel with your travel dates and mention the
   conference code SIT0524.

 * The hotel will send a form to request the credit card details, once the hotel
   has received the credit card details, the booking confirmation will be sent.

 * The hotel costs must be paid upon departure.

 * Prices include breakfast, but exclude city tax.

 * Costs for reserved rooms are subject to the cancellation policy of the
   respective hotel




HOTELS

Hotel America

Price per night: CHF 174.00
Hotel Website: Hotel America
E-Mail: info@hotelamerica.ch



Hotel Belvedere (the venue)

Price per night: CHF 240.00-260.00
Website Hotel: Hotel Belvedere
E-Mail: info@belvedere-locarno.com



Hotel Ibis

Price per night: CHF 179.00
Website Hotel: Hotel Ibis
E-Mail: H6834@accor.com



Hotel La Rinascente

Price per night: CHF 214.00
Website Hotel: La Rinascente
E-Mail: info@hotel-rinascente.ch



Hotel Rio

Price per night: CHF 149.00
Website Hotel: Hotel Rio
E-Mail: info@garni-rio.ch



TRAVEL INFORMATION


Travelling by air



The closest airports to Locarno are


 * Milano Malpensa Airport, Italy
   o 60 km away from Locarno
   o train from the airport to Locarno: 2h 16m
   
   

 * Milano Linate Airport, Italy
   o 130 km away from Locarno
   o Train from the airport to Locarno: 2h 40m
   
   

 * Zürich Kloten Airport, Switzerland
   o 216 km away from Locarno
   o Train from the airport to Locarno: 3h 30m



Travelling by train

Locarno railway station. Regular trains link Locarno directly with Bellinzona
(change train) from where you can transfer onto trains to Zurich, Basel,
Lucerne, Milan.

Link to the Swiss Railway System SBB



How to get to the venue

How to reach the Hotel Belvedere, where the inspectors' training takes place:

 * From the center of Locarno on foot approx. 15 minutes

 * From the railway station on foot approx. 15 minutes

 * With the Funicolare from the railway station to Hotel Belvedere (stop Hotel
   Belvedere) 3 minutes
   
   
   
   
   
   
   
   
   

Google Maps Funicolare station

Google Maps Hotel Belvedere




EVENING PROGRAM FOR TUESDAY 14 MAI 2024

Swissmedic invites all participants in the Inspector Training to a typical
Ticino evening in the Caverna degli Dei on Tuesday. This grotto is located on
the world-famous Piazza Grande in Locarno, in the Hotel America.


 * Meeting point: from 18:30 Apero at the Hotel America on the Piazza Grande in
   Locarno

 * Dinner at approx. 19:30 in the Caverna degli Dei (Hotel America)

 * The events ends at approx. 22:00




SOME IDEAS TO DISCOVER LOCARNO

Locarno, together with Lugano, is the warmest place in Switzerland. We are
hoping for mild and sunny days during the inspectors' training so that we can
show you Switzerland's sunniest city in all its splendour.

Below you will find a few ideas on how to spend the time before and after the
meetings.


Dolce far niente

The best thing you can do in Locarno is the sweet, typically southern way of
doing nothing. And the best way to do this after a hard day's work is with a
cool drink on the Piazza Grande.



Refreshment in the lake

How about a dip in Lake Maggiore? Swimming in the lake is completely safe and
the Swiss love to cool off in the lake after an intensive day. The only
obstacle: the rather cool water temperatures in May. The average water
temperature in May of Lake Maggiore is 15 degrees Celsius.



Visit to the sacred mountain

Our conference venue, the Hotel Belvedere, is located halfway to the Madonna del
Sasso pilgrimage church. The magnificent church is situated on a rocky outcrop
from where you can enjoy a breathtaking view of the town and the lake as far as
Italy.


The funicular railway "Funicolare" takes you from the intermediate station Hotel
"Belvedere" to the Sacro Monte Della Madonna del Sasso stop in just a few
minutes (stop on request).


The funicolare runs every 15 minutes in both directions. The journey time back
to Locarno is 9 minutes. From the valley station you can reach Piazza Grande in
5 minutes.



Stroll through the old town

There is so much to discover on a stroll through Locarno's old town: chic
boutiques, cosy cafés, stately homes and churches. The narrow streets give the
town a picturesque atmosphere steeped in history. And all roads lead to the
famous Piazza Grande.



Walk to Ascona

The former fishing village of Ascona is now a popular and somewhat fashionable
holiday resort. Ascona is the lowest-lying village in Switzerland, as the
village centre lies directly on the lake. Accordingly, the lakeside promenade
invites you to take a stroll. Walk to Ascona in 30 minutes or take the bus. The
journey is free with the "Ticino Ticket". You will receive the Ticino Ticket on
arrival at your hotel.




CONTACT

If you have any questions, please contact the following persons:




Programme co-ordination and content

Barbara Suzanne Herzog
Inspector
Phone + 41 58 480 87 45
barbara.herzog@swissmedic.ch




Organisation & Administration

Nicole Lüthi
Communication Department
Phone +41 58 463 71 99
nicole.luethi@swissmedic.ch