Pharma Microbiology Congress 25 Insights – Focus on Rapid Microbiology Methods (Session 2 & 6)

Program

SESSION 2 – INDUSTRY’S JOURNEY TOWARDS RAPID METHODS: PERSPECTIVES AND APPLICATIONS

Introduction by the Chairperson
Alice Le Gatt, Global Change Facilitator | BioPhorum

Industry’s Journey towards Rapid Microbiological Methods: A BioPhorum Perspective
Alice Le Gatt, Global Change Facilitator | BioPhorum
Caitlin Cooke, Scientist, Global Product Development, Pharmaceutical Technology and Development | AstraZeneca

Project Management and Validation Strategy of Growth Direct System for Environmental Monitoring and Water-Bioburden
Miriam Meinersmann, Expert GMP Compliance and Documentation Microbiology and Monitoring Quality Control | Daiichi Sankyo Europe GmbH, Germany
Franziska Graf, Trainee Microbiology and Monitoring Quality Control | Daiichi Sankyo Europe GmbH, Germany

Implementation roadmap of OWBA in Pharma, with use-case of implementing enzyme activity-based OWBA on PW/WFI
Sebastian Strandberg Rutell, Associate Process Engineer in PAT | Novo Nordisk

Regulatory Focus by PEI
Oleg Krut, Head of Microbial Safety Department | Paul-Ehrlich-Institut (PEI)

Round Table
Moderator: A. Le Gatt
Participants: C. Cooke, F. Graf, O. Krut, M. Meinersmann, S. Strandberg Rutell, Johannes Oberdorfer | Rapid Micro Biosystems, Allison Scott | Member of Modern Microbial Methods (M3) Collaboration

SESSION 6 – KEY CONSIDERATIONS – Regulatory requirements for Alternative Methods: adoption & implementation

Focus on Ph. Eur. 5.1.6. commenting phase and USP <1071>, <72> and <73> updated release
Lucia Ceresa, Freelance Pharmaceutical Consultant & PDA Italy Chapter Board

Q&A Time
Lucia Ceresa, Freelance Pharmaceutical Consultant & PDA Italy Chapter Board

Pharma, Biotech and Medical Device Companies, Regulatory bodies and Technology Suppliers involved in the manufacturing and control of Sterile medicines.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.