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Parenteral Drug Association Connecting People, Science and Regulation ®

Risk Management in Technology Transfer

The Most Important Aspects of PDA Technical Report # 65
Nov 08 - Nov 09, 2018 |
Nov 09, 2018 |
MELIÁ SEVILLA | Seville, Spain
  • Conference
  • Europe
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Nowadays technology transfer projects are a reality in the pharma markets. For several reasons, manufacturing process and related activities (i.e. analytical, development, quality, operation excellence) are moved intra companies and inter companies. Due to the high number of risks associated with the safe robust and in compliance manufacturing of a drug, an appropriate risk management approach and appropriate skills have to be in place in the transferring and receiving site. Following the main international guidance, such as technical report 65 and ICH, this workshop will guide the attendees through a technology transfer process and its risk management and provide insights and practical guidance for developing internal robust procedures, skills and approaches.

Who Should Attend

Subject matter experts coming from different areas such as

  • Production
  • QA
  • Validation
  • Engineering (involved in process/equipment design)
  • RA
  • QC (involved in analytical transfer)
  • Project Managers and Technology Transfer Managers are key

Learning Objectives

  • Understand principles, main documents and main steps of a technology transfer process (internal and external)
  • Identify risks in technology transfer processes
  • Evaluate risks and put in place appropriate mitigation plan
  • Understand main roles and responsibilities of the stakeholders of technology transfer process • Create high level internal procedures for handle technology transfer

Instructor

Mirko Gabriele, Global Technology Transfer Senior Manager, Patheon
Mirko joined Patheon in 2008 and has held various positions, including Technology Transfer Project Manager, Technical Business Manager and Manager of Technology Transfer Responsibility for the Ferentino team. He also has experience in Quality Control and Research and Development, both in Finished Products and API companies. Mirko led the Parenteral Drug Association (PDA) Group issuing the Technical Report 65 on Risk Management during Technology Transfer and is currently leading the PDA Global Technology Transfer Interest Group. He is member of the PDA Regulatory Affairs and Quality Advisory Board since 2014. Mirko received a Master Degree in Chemical and Pharmaceutical Technologies in 2004 at the University of Rome and in 2012 and Executive MBA in Pharma Administration at the Luiss Business School of Rome. Mirko is Qualified Person for the Italian Health Authority since July 2014.

Thursday, 8 November 2018

9:00
Welcome & Attendees Introduction


9:00
Technology Transfer – Definition and Main Principles

  • Opportunities along product lifecycle
  • Regulatory guidance on technology transfer
  • Planning and Social Intelligence
  • Tool for planning

10:00
Technology Transfer – Definition and Main Principles (continued)

  • Tool for Social Intelligence
  • Role and responsibility
  • General org chart in technology transfer

11:00
Coffee Break

11:30
Technology Transfer Project Management Tools

  • Timelines
  • Leadership
  • Communication

12:30
Lunch Break

13:30
Technology Transfer Documentation

  • Technology Transfer Plan
  • Technology Transfer Report
  • Feasibility batches Protocol and Report

14:30
Technology Transfer Procedures


15:30
Coffee Break

16:30
Analytical Transfer

  • General approach (transfer vs validation)
  • Analytical Master Plan

17:00
Recap of the Day


17:30
End of Day 1

Friday, 9 November 2018

9:00
Recap of the Main Concepts of Day 1


09:30
Introduction into Technical Report TR 65

  • Project staging
  • Risks in technology transfer
  • Risk Management in technology transfer

10:30
Introduction into Technical Report TR 65 (continued)

  • Severity/Occurrence/Detection in technology transfer
  • FMEA

11:00
Coffee Break

11:30
TR 65 – Case Study 1 'Analytical Method Transfer (AMT)'

  • Design of Comparative AMT Test Studies
  • Selecting AMT Performance Characteristics
  • AMT Documents

11:45
Step 7: Verify Corrective/Preventive Actions

  • Implement & measure corrective/preventive actions
  • Evaluate control plan
  • Determine additional preventive actions

12:30
Lunch Break

13:30
TR 65 – Case Study 2 'Manufacturing Process Transfer'

  • Overvew of Manufacturing Process Transfer
  • Development to Commercialization Technology Transfer Process
  • Intracompany Technology Transfer Process

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

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

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

MELIÁ SEVILLA
Calle Dr. Pedro de Castro 1
41004 Sevilla
Spain
Tel: +34 912 76 47 47
Hotel Website

Located in the heart of Seville opposite the Parque de Maria Luisa and Plaza España and very close to the University (Old Tobacco Factory), the Alcazar, the Barrio de Santa Cruz district, the Cathedral and the Archive of the Indies, the new Meliá Sevilla is the perfect choice for your business and leisure trips, thanks to its excellent location in the city centre, its fully equipped and comfortable facilities and the quality of its services.

Completely refurbished, the hotel offers a stunning outdoor pool with views of Plaza España and a spectacular Congress and Convention Centre. All the rooms at the new Meliá Sevilla are outward facing, comfortable and bright.

The hotel’s Mosaico restaurant serves an international breakfast buffet. There is also a poolside snack bar and a chic cocktail lounge, Elyxr.

PDA Europe has reserved a limited number of rooms until the 12th September 2018

Single Room € 95 per night; 10% VAT, additional taxes and service charges will apply *
Double Room € 106 per night; 10% VAT, additional taxes and service charges will apply*

*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)

How to Get There

Seville Airport– SVQ
Airport Phone: +34 954 44 90 00
Hotel Direction: 11.8 km
The airport shuttle service is upon request for €25 per vehicle one way.

Parking

Parking available upon request at the registration desk.

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://www.pda.org/docs/default-source/website-document-library/eu-conferences/2018/11_outsourcing/registration-form.pdf

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