Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Best Practices and Points to Consider in Aseptic Processing

Oct 17 - Oct 18, 2018 |
Oct 18, 2018 |
Berlin Mariott Hotel | Berlin, Germany
  • Education
  • Europe
Add event to: ICal Outlook Google Calendar

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”.

Wednesday, 17 October 2018

9:00
Welcome and Collection of Participant Expectations


9:30
Introductional Test about Selected Hot Topics in Aseptic Processing

  • Discussion of answers

10:30
Coffee Break

11:00
Important Aspects of Sterilization, Cleaning and Disinfection, Gowning Procedures

  • Steam & Dry Heat Sterilization
    • Technical Report 1 (TR 1) Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification
    • TR 3 Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
    • TR 48 Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification and Maintenance
    • TR 61 Steam in Place
  • Key elements for Cleaning & Disinfection in cleanrooms
    • TR 70 Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing
  • Gowning steps for entering grade A/B area

12:30
Lunch Break

13:30
Aspects of Clean Room Concepts and Good Aseptic Working Practices

  • Conventional filling lines
  • RABS systems and isolators
  • Understanding First Air and barrier concepts
    • TR 62 Recommended Practices for Manual Aseptic Processes
  • Points to Consider for Aseptic Processing: Part 1 & Part 2
  • Update on TR 34 Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products

14:30
Team Excercise 1: How to Maintain an Aseptic Environment


15:30
Coffee Break

16:00
Effective Oversight at the shop floor, Good Training Methods

  • Regulatory requirements and framework
  • Sharing my best practices and effectiveness
  • Examples from the shop floor worldwide

17:45
End of Day 1

Thursday, 18 October 2018

9:00
Best Practices in Aseptic Processing Simulation

  • Basic Concepts and Regulatory Framework about Process Simulations
  • Best Practices in Media Fills for Finished Dosage Form and API
    • TR 22 Process Simulation for Aseptically Filled Products
    • TR 28 Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
  • (Re)Qualification of Operators
  • Categorization of Interventions

10:00
EU Annex 1 Revision

  • Selected Comments from the PDA Taskforce

10:30
Coffee Break

11:00
Important Aspects in Environmental Monitoring

  • TR 13 Fundamentals of an Environmental Monitoring Program
  • Regulatory requirements and expectations
  • Rationale for sample locations and frequency
  • How to proceed in case of excursions

11:30
Team Exercise 2: Set-up a EM Program for Cleanrooms/Isolators


12:30
Lunch Break

13:30
Team Exercise 3: Share your own case studies and problems, and find resolutions as a team


15:00
Coffee Break

15:30
Team Exercise 4: Benchmarking between team members


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 Marriott 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 14th August 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=4248

Directions