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2019 Visual Inspection Week

Why Quality Culture? More Success by Reducing Human Errors

May 22 - May 23, 2019
Berlin, Germany

A good quality culture is established when all employees starting from CEO to shop floor workers are accountable for quality.

  • Education
  • Europe

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Program Highlights

Overview

A good quality culture is established when all employees starting from CEO to shop floor workers are accountable for quality.

The following attributes are important indicators for quality culture: management communication emphasizing that quality is everyone’s responsibility, established quality improvement objectives, quality topics included in relevant meetings, and an implemented error prevention process.

These quality attributes are related to management responsibility and are elements of the continuous improvement of the pharmaceutical quality system as mentioned in the ICH Q10 guideline.

Quality culture is a key management element for success. However, quality culture does not establish itself but requires empowerment,communication and daily quality awareness.

Agenda

  • Day 1
  • Day 2
  • Wednesday, 22 May 2019

    9:00
    Welcome & Introduction


    9:30
    Lecture 1: Definition: What Does Quality Mean?


    10:15
    Lecture 2: Quality Behaviors


    10:45
    Coffee Break

    11:15
    Interactive Session 1: Bad and Good Behaviors


    11:45
    Interactive Session 2: Assessment Exercise


    12:15
    Lunch Break

    13:15
    Lecture 3: Investigation Principles


    14:00
    Interactive Session 3: Root Cause Investigation Exercise


    14:45
    Coffee Break

    15:15
    Interactive Session 3: Root Cause Investigation Exercise (continued)


    17:00
    Lecture 4: Correction, CAPAs, Effectiveness Check


    17:30
    Recap of Day 1, Forecast to Day 2


    17:45
    End of Day 1

    Thursday, 23 May 2019

    9:00
    Recap of Day 1, Forecast to Day 2


    9:15
    Lecture 5: Toolbox for Improvement of Quality Behaviors


    10:00
    Interactive Session 4: Toolbox Assessment


    10:30
    Interactive Session 5: Improvement of Quality Behaviors


    11:00
    Coffee Break

    11:30
    Interactive Session 5: Improvement of Quality Behaviors (continued)


    12:00
    Lecture 6: Cost-Time-Quality Dilemma


    12:30
    Interactive Session 6: Optimized Quality Culture


    13:00
    Lunch Break

    14:00
    Interactive Session 6: Optimized Quality Culture (continued)


    14:30
    Lecture 7: What is an Ideal Quality Culture in a Company?


    15:20
    Break

    15:30
    Exchange of experience with improvement of Quality Culture


    16:00
    Summary and Conclusion


    16:15
    Questions & Answers


    16:30
    End of Course
  • Thursday, 23 May 2019

    9:00
    Recap of Day 1, Forecast to Day 2


    9:15
    Lecture 5: Toolbox for Improvement of Quality Behaviors


    10:00
    Interactive Session 4: Toolbox Assessment


    10:30
    Interactive Session 5: Improvement of Quality Behaviors


    11:00
    Coffee Break

    11:30
    Interactive Session 5: Improvement of Quality Behaviors (continued)


    12:00
    Lecture 6: Cost-Time-Quality Dilemma


    12:30
    Interactive Session 6: Optimized Quality Culture


    13:00
    Lunch Break

    14:00
    Interactive Session 6: Optimized Quality Culture (continued)


    14:30
    Lecture 7: What is an Ideal Quality Culture in a Company?


    15:20
    Break

    15:30
    Exchange of experience with improvement of Quality Culture


    16:00
    Summary and Conclusion


    16:15
    Questions & Answers


    16:30
    End of Course

Trainers

Martin   Haerer
Martin Haerer
Holopack Verpackungstechnik GmbH
Thomas Krieger
Thomas Krieger
KU-Pharma Consulting

Additional Information

  • Learning Objectives

    Learning Objectives

    This training course is interactive, hands-on, and will empower you to measure, develop and improve the quality culture of your company:

    • Learn to measure quality attributes and quality behaviors
    • Identify weaknesses and deficits in quality behavior
    • Investigate root causes and define effective CAPAs for improvement
    • Optimize your measures with respect to cost, time and quality
  • Who Should Attend

    Who Should Attend

    Functions:

    • Middle Management
    • Managers with employee responsibility
    • Group Leaders
    • Department Heads
    • Directors
    • Executive Level

    Functions:

    • Quality Assurance
    • Quality Control
    • Production
    • Purchasing
    • Regulatory Affairs
    • R&D
    • Human Resources
    • Controlling
  • 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:

    PDA # / ACPE # / CEUs:
    Type of Activity: Not Applicable

    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.
    Continuing Education for Professional Engineers
    New Jersey

    PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

    The credit value of this course is CPC credits.
    North Carolina

    PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDH) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

    The credit value of this course is PDH credits.

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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.

Berlin Mariott Hotel

Axel Springer Strasse 55
Berlin, Germany

Make a Reservation
Berlin Mariott Hotel
  • Accommodations

    Hotel Website

    The Courtyard Berlin City Center is situated in the heart of the action, placing you near landmarks like Checkpoint Charlie, Potsdamer Platz, Brandenburg Gate and Alexanderplatz. You'll find it easy to relax in your modern, well-appointed hotel lodging; all of the spacious rooms showcase free high-speed Wi-Fi access, luxurious bedding, an ergonomic desk, a mini-fridge and more. Fuel up for your morning in the Mitte district with a hot breakfast buffet at Oléo Pazzo, or end your day with a delicious Mediterranean meal.

    We also provide a fully equipped fitness center, a sauna and an on-site coffee house. Host a meeting or social event with us here in Berlin city center to make use of 8,342 square feet of versatile venue space, cutting-edge event technology and innovative planning and catering. Make the Courtyard Berlin City Center your destination of choice for your visit to the Mitte district.

    PDA Europe has reserved a limited number of rooms until the 08th April 2019.

    Book Your Room for the PDA Group Rate
    Single Room € 135 per night*
    Double Room € 150 per night*

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • usage of Wireless LAN
  • Amenities

How to Get Here

By Air

Nearest Airports:

Berlin-Tegel Airport - TXL
Airport Phone: +49 30 60911150
7.1 mi (11.42 km), 22 min by car
Estimated taxi fare: 28 EUR (one way)
Bus service, fee: 2.7 EUR (one way)
Subway service, fee: 2.7 EUR (one way)
Take the bus X9 and get off at the Zoological Garden. Change to the subway U2 towards Pankow and get off at Spittelmarkt. Cross Seydelstrasse and turn right. The hotel will be on the right.

OR

Berlin-Schoenefeld International Airport - SXF
Airport Phone: +49 30 60911150
11.7 mi (18.9 km), 23 min by car
Estimated taxi fare: 40 EUR (one way)
Bus service, fee: 3.3 EUR (one way)
Subway service, fee: 3.3 EUR (one way)
Take the bus SX1 to Südkreuz. Then change to bus 248 to S+U Bahnhof Alexanderplatz and get off at Lindenstrasse/Oranienstrasse. Turn right into Axel-Springer-Strasse, direction Axel-Springer building. The hotel is located at the very end of the street on the left hand side.

By Car

The Marriott Berlin City Center is located at Axel Springer Strasse 55.

Other Options

Bus station: Spittelmarkt, 0.1 miles.

Subway station: Spittelmarkt, 0.1 miles.

Train station: Hauptbahnhof, 3.1 miles.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €1.595

All fees given in Euro and excluding VAT

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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.

Special Dietary Requirements

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).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

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 registration@pda.org. Phone messages are not accepted.

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Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
TRI@pda.org

Tel: +49 (0) 30 43 655 08-10

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Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

 

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