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Introduction
Rephine Virtual Symposium is an annual event which was delivered online previously with great success in 2021.
The Symposium is a great opportunity to deliver our deep domain expertise within the Quality Assurance scope.
Intended audience
This event is addressed to all professionals that are involved in the Supply Chain of raw materials for the pharmaceutical industry. Especially for those professionals in:
SESSION 1
09:00 – 09:15h Welcome to the Symposium.
Adam Sherlock. Rephine CEO.
09:15 – 09:30h Why this Symposium?
Chris Burman. Rephine VP Commercial
09:30 – 10:30h Evolving with Good Manufacturing Practice: harnessing the new risk-based approach to improve proactivity & process efficiency.
Dr. Eduard Cayón. Rephine VP Audit Services.
SESSION 2
10:45 – 11:00 h Auditing Best Practices – Gold Standard approach (I)
Absence of conflict of Interest
Confidentiality and Full transparency
Alasdair Leckie. Rephine VP GMP Operations
11:00 – 11:30 h Auditing Best Practices – Gold Standard approach (II)
Audit preparation, risk based
Auditor expertise and knowledge
Reporting focussed to QP needs
José Carlos Vergara & Tábata Bortuni. Rephine Heads of technical department
11:30 – 11:45 h Auditing Best Practices – Gold Standard approach (III)
Quality Oversight of auditing process
Aina Sellés. Rephine Quality Director
SESSION 3
11:45 – 12:30 h GMP 2023 Trends Roundtable
(Anna Cluet, Eduard Cayon, Vera Wang)
Closing remarks: Adam Sherlock
SESSION 4
09:00 – 10:00h Digitalisation of manufacturing quality management: optimising the potential by redesigning processes.
Marian San. Rephine VP Consulting.
Sandra Lacruz. Pharmaceutical Senior Consultant
SESSION 5
10:15 – 11:00h GMP & Quality data integrity: how to approach & demonstrate this.
Sergi Arcas. Rephine Senior Consultant CSV
SESSION 6
11:00: – 11:30 h Importance of eQMS in the pharmaceutical industry (Trackwise Case Study).
Victor Samitier. Rephine Trackwise Delivery Manager. Trackwise area manager
Roberto Palomar: Rephine Trackwise Delivery Consultant
SESSION 7
11:30 – 12:00 h Digital transformation of paper-based validation methodologies
(Valgenesis Case Study).
Juan Torrijos. Rephine Validation & GMP Consultant. Valgenesis area manager
SESSION 8
12:00 – 12:30 h News on European Regulatory framework for Medical Devices
Laia Paris. Rephine Medical Device consultant.
Closing remarks: Adam Sherlock
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