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Rephine Virtual Symposium 2023

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:

  • Qualified Persons and Quality Directors
  • Purchasing or Quality departments of Pharmaceutical companies
  • Chemical Distribution companies
  • EU GMP inspectorates
  • API and Excipients manufacturers

                                               REPHINE SYMPOSIUM 2023

 

Live online event

April 17th – 18th, 2023

 

PART 1.

April 17th, 2023. 9:00 am to 12:30 pm GMT

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

 

PART 2.

April 18th, 2023. 9:00 am to 12:30 pm GMT

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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