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Parenteral Drug Association Connecting People, Science and Regulation ®

Best Practices and Points to Consider in Aseptic Processing

Nov 09 - Nov 10, 2017 |
Nov 10, 2017 |
| Vienna, Austria
  • Education
  • Europe
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Aim of this training course is to facilitate a deeper understanding and provide insights into the Aseptic Processing environment, and to go beyond what is commonly covered in books on that subject. A practical and highly interactive approach will enable participants to get actively involved, discussing guidelines and Warning Letters in addition to sharing perspectives and solutions to issues found in everyday job situations.

A kaleidoscope of hot topics such as Best Practices and Case Studies from different areas of Aseptic Processing, Sterile Production facilities, QA/ QC Microbiology Control, Shop Floor Mentoring and Oversight will be addressed. Training and Motivation of staff, use of Risk Assessments and Quality Culture are further relevant aspects.

Lively interactions will make this a valuable learning experience for all.

Who should attend?

Personnel involved in Aseptic Processing from sterile production departments such as:

  • Production Management and Shop Floor Supervisors
  • QA and QC Microbiologists
  • Qualified Persons
  • Personnel from technical department
A basic understanding of Aseptic Processing is a prerequisite.

 

Learning Objectives

  • Gain deeper knowledge and insights into specific topics like sterilization, training and motivation of shop-floor staff, correct aseptic working practices, media fill worst case criteria, effective environmental monitoring programs, good cleaning & disinfection practices, etc.
  • Understand key requirements and challenges in parenteral production
  • Understand the importance of a good quality culture within a company
  • Apply the executed and presented case studies and team exercises in her/his daily job
  • Get answers and interpretations about - potentially - unresolved questions and problems
  • Gain confidence for audits

Instructor

Guenther Gapp, PhD, Independent Consultant, Gapp Quality GmbH

Since 2013, the microbiologist Guenther Gapp has been working as an independent consultant for different clients around the globe, and has been engaged in more than 30 projects: recently at US- Lachman Consultants as “Aseptic Processing Expert”, e.g. in assignments for remediation of companies cited with a Warning letter. In the previous steps of his career, he served in the pharmaceutical industry during 20 years as Head of QA/QC Microbiology department and Sterility Assurance Expert and Troubleshooter in global projects and supplier audits. During this period, he gained in-depth experience in Aseptic processing key elements, Training and motivation of operators, media fill practices of finished dosage forms and bulk products, environmental monitoring, rapid testing methods and regulatory agency audits. Guenther has been a subject matter expert in more than 20 FDA audits. He also created a new sterile risk assessment tool to identify and reduce the microbial contamination and compliance risk of aseptically prepared, sterile products, and this method is used now worldwide. The publication of this Risk Assessment tool won him the 2011 PDA Journal of Pharmaceutical Science and Technology Award. He has been a speaker at several PDA conferences in the past years. Since 2017 he is also a member of the 2017 PDA Annex 1 Workshop committee and Task Force, which deals with the revision of the important European guidance Eudralex Annex 1 “Manufacture of Sterile Medicinal Products”.


Thursday, 9 November 2017

9:00
Welcome

9:30
Introductional Test about Selected Hot Topics in Aseptic Processing - Discussion of Answers

10:30
Coffee Break

11:00
Importance of a Good Quality Culture in Aseptic Processing – What May Go Wrong

11:30
Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

12:30
Lunch Break

13:30
Aspects of Clean Room Concepts and Good Aseptic Working Practices - Conventional Filling Lines, RABS Systems and Isolators

14:30
Team Exercise: Preparing a New Concept for Start-Up of an Aseptic Filling Line

15:30
Coffee Break

16:00
Hot Topics in Pharmaceutical Water Systems and Best Control Practices

16:30
Effective Oversight at the shop-floor, Good Training Methods

18:00
End of Day 1

Friday, 10 November 2017

9:00
Guidance How to Execute in Media Fills and Process Simulations (Definition of Worst Case Criteria), Sterile Active Product Ingredients, PDA TR 22

10:00
EU Annex 1: What Are the Changes

10:30
Coffee Break

11:00
Important Aspects in Environmental Monitoring and Team Exercise, PDA TR 30

12:30
Lunch Break

13:30
Applications of Risk Assessments for Microbial Contamination Control and for Supporting Decisions in Case of EM-Deviations (HAZOP and FMEA)

14:30
Selection of Case Studies About Microbiological Deviations, Related Root Causes and CAPAs in Aseptic Processing

15:30
Coffee Break

16:00
Summary & Discussion of Open Questions

16:30
End of Course

4 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

All fees given in Euro and excluding VAT (23%)

Contact

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

Austria Center Vienna
Internationales Amtssitz- und Konferenzzentrum Wien, AG
Bruno-Kreisky-Platz 1
A-1220 Vienna

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2017 . We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

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://www.pda.org/docs/default-source/website-document-library/eu-conferences/2017/the-universe-of-prefilled-syringes/registration-form.pdf

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