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2019 Annual

Interest Group Meeting Quality Systems

Jun 24, 2019
Amsterdam, Netherlands

  • Interest Group
  • Europe
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Overview

PDA is happy to announce the Interest Group Quality Systems!

As usual for any PDA Interest Groups, members are offered the possibility to discuss around their specific topic of interest, via an online forum and face-to-face as part of a conference.

Presentations around:
  • Quality Management Systems
  • Integration of Quality Risk Management in QMS
  • Best Practices for conducting Management Reviews

Group Discussions on the topics of:

  • Management Review
  • KPIs / Metrics
  • CPV
  • Process Owner
  • Quality Risk Management
  • Comparability of ICH Q10 with ISO
  • Knowledge management
  • PQS Implementation
  • Processes / Flow Charting

You do not need to be a PDA member to register for this meeting. Everybody is welcome!

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Agenda

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  • Monday, 24 June 2019

    10:00
    Welcome & Introduction

    10:30
    Opening of the Meeting & Introduction of the IG QS EU
    Lothar Hartmann, Phact

    11:00
    KEY NOTE PRESENTATION

    "Big Data"
    What does the future look like?
    Toni Manzano, Bigfinite

    SUB-GROUP'S FLOOR

    11:45
    Comparability of ICH Q10 with ISO 9000
    Heribert Dahmen, Merck

    12:15
    CPV
    Agnès Hardy-Boyer, Sanofi-Pasteur

    12:45
    Lunch Break

    SUB-GROUP'S FLOOR (contin'd)

    13:30
    Process Owner
    Sofia van Berlekom, AstraZeneca

    14:00
    Management Review
    Pia Sandau, Novo Nordisk

    WORKSHOPS SESSION

    14:30
    Group 1:
    Does the PQS/QMS fit into the true lifecycle (ICH Q8 – 14)?
    Lothar Hartmann, Phact

    Group 2:
    What does a QMS look like in a digitalised world?
    Jeremie Arrault, Novartis
    Michele Simone,     Bracco
    15:30
    Coffee Break

    16:00
    PLENARY DISCUSSION
    Presentation and Conclusions of the Discussions from the Workshops
    Lothar Hartmann, PhACT

    17:00
    End of IG Meeting

Highlighted Speakers

Jeremie Arrault
Jeremie Arrault
Novartis
Heribert Dahmen
Heribert Dahmen
Merck KGaA
Agnes Hardy-Boyer
Agnes Hardy-Boyer
Sanofi-Pasteur
Lothar Hartmann
Lothar Hartmann
IG Leader, Phact
Toni Manzano
Toni Manzano
Bigfinite
Pia L. Sandau
Pia L. Sandau
Novo Nordisk
Michele Simone
Michele Simone
Bracco Suisse
Sofia van Berlekom
Sofia van Berlekom
AstraZeneca

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hilton Amsterdam

Apollolaan 138
Amsterdam, Netherlands
Phone: +31(0)20 7106000

Hilton Amsterdam
  • Accommodations

    Hotel Website

    The iconic hotel, steeped in history and refinement, sits in the luxurious residential area of Amsterdam, a 10-minute walk from attractions like Rijksmuseum and Vondelpark. The elegant rooms - such as the famous John & Yoko Suite - provide the comfort you seek alongside amenities like the equipped Health Club. Explore fine Italian cuisine at Roberto’s or creative cocktails and a spacious garden terrace at Half Moon Lounge.

    Hosting up to 700 guests in our 21 meeting areas, only 20 minutes from Schiphol and close to RAI Convention Center & World Trade Center, the hotel offers a private entrance, on-site parking and a marina backdrop.

    PDA Europe has reserved a limited number of rooms until the 18th April 2019.
    Book Your Room for the PDA Group Rate

    Single Room € 256 per night*
    Double Room € 277 per night*

    *Rates are per room and night, including the following services and benefits
    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, excluding 6% city tax
  • Amenities

How to Get Here

By Air

Nearest Airport: Schiphol - AMS
Airport Phone: +31 20 794 0800

By Car

15 km, 20 min by car.

Take the A4 onto the A10 and exit at Amstelveen/S108. Turn right at traffic lights onto Amstelveenseweg. Turn right onto Stadionweg. Follow the Hilton signs onto Olympiaweg. Turn right onto Apollolaan. Turn left at 3rd traffic light.

The Hilton Amsterdam is at Apollolaan 138, Amsterdam, 1077 BG, Netherlands.

Other Options

Subway/rail: 5.00 EUR.

Taxi: 35.00 EUR.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €350

All fees given in Euro and excluding VAT (21%)







* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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