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Parenteral Drug Association Connecting People, Science and Regulation ®

Practical Approach to Quality Culture

Jun 28 - Jun 29, 2018 |
Jun 29, 2018 |
Berlin Mariott Hotel | Berlin, Germany
  • Education
  • Europe
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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.

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

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

Instructors

Thomas Krieger, Ph.D, CEO, KU-Pharma Consulting
Thomas Krieger is founder and CEO of Krieger Unternehmensberatung - Pharma (KU-Pharma) since 2009. KU-Pharma is mainly specialized on providing quality consulting for the pharmaceutical industry. In addition, KU-Pharma is providing career-readiness-training to high-potentials and coaching to managers who take on new tasks or assume new legal functions according to the drug law. Thomas studied pharmacy and obtained his Ph.D. degree in Pharmaceutical Chemistry from the University of Tuebingen, Germany. He graduated as specialized pharmacist of Pharmaceutical Analysis. Since 25 years he holds the legal qualification and has professional experience as a Qualified Person pursuant to Directive 001/83/EC. During 20 years Thomas Krieger has held different legal functions according to the drug law and various senior management and leadership positions in quality control, quality assurance, regulatory affairs and scientific departments. He worked for several pharmaceutical companies within the range from Global Players with more than 50,000 employees to private owned companies with less than 100 employees.


Martin Haerer, Senior Director R&D/Qualified Person, Holopack Verpackungstechnik GmbH
After the Ph.D. in Pharmacy, Martin started his career at Holopack Verpackungstechnik in 1990. In the following years, he managed different projects in Production, Quality Control and Quality Assurance to improve the Quality System and Production. In 2006 he was appointed Production Manager and Qualified Person. Currently he is responsible for Business Development, Technology Transfer and Research, and still acting as Qualified Person with QA responsibilities. Martin was voted Member of the Board of the BFS-IOA Association as Regulatory Officer. He is member of the German QP Association and Board Member of Federal German Pharmacist Advanced Training Organisation (BAK).

Thursday, 28 June 2018

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

Friday, 29 June 2018

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

3 Ways to register

Please remember to log in if you are a member of PDA already! 

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1495 Euro

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66

Exterior

Berlin Mariott Hotel
Inge-Beisheim-Platz 1
10785 Berlin
Germany
Tel: +49-30-220000
Hotel Website

Showcasing spacious, impeccably appointed guest rooms and suites, a host of first-class amenities, and an unbeatable location in the heart of the city centre, the Berlin Marriott Hotel offers a seamless blend of comfort, style and convenience for your visit to Germany's capital city.

Unwind in the well-appointed hotel rooms, each of which boasts deluxe bedding, a flat-screen TV, an ergonomic workspace and a mini-bar. You'll enjoy the wide variety of outstanding on-site resources, such as a state-of-the-art fitness center and indoor pool, an authentic steakhouse and a sleek, inviting hotel bar.

Guests looking to host a successful meeting or wedding here in Germany will be thrilled with the 18,277 square feet of sophisticated event space, the expert planning and catering teams and the accessible location in Berlin city centre. The hotel is situated two blocks from Potsdamer Platz, and near the Brandenburg Gate and the Gendarmenmarkt. Allow the Berlin Marriott Hotel to redefine the meaning of contemporary elegance.

PDA Europe has reserved a limited number of rooms until the 12th May 2018.
Book your room for the PDA Group Rate.

Single Room € 195 per night*
Double Room € 215 per night*

*Rates are per room and night, including the following services and benefits free of charge:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI)
  • VAT, Taxes and Service Charge will apply

How to Get There

Berlin-Tegel Airport – TXL
Airport Phone: +49 30 60911150
Hotel direction: 5.6 miles SE

Berlin-Schoenefeld International Airport – SXF
Airport Phone: +49 30 60911150
Hotel direction: 12.3 miles NW

This hotel does not provide shuttle service.

Parking

  • On-site parking, fee: 3.5 EUR hourly, 30 EUR daily

Photos

Sponsorship and Exhibit Opportunities are Available!

For more information about exhibit and sponsorship opportunities, please contact:

Nadjeschda Gomez-Stahl
Manager Exhibition & Sponsorship
Tel: +49 (0) 30 43 655 08-23
Fax: +49 (0) 30 43 655 08-66
Email

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4167

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