Pharma Automation & Digitalization: Pioneering the Future of Healthcare

We have been successfully organizing several trainings so your business can adapt to constantly evolving market demands and regulations. Leading pharmaceutical and biotech companies are re-assessing the processes and digital tools (incl. information systems) they use to collect, handle, and organize QC laboratories’ data. The proposed update of Annex 11 by EMA and PIC/S in November 2022 looks to include regulatory expectations for digital transformation. Pharma Laboratory Automation & Digitalization course was designed to provide an in-depth understanding of redesigning processes to automate & digitize them. Additionally, a great space is dedicated to discussions about how to overcome regulatory & business risks. The course is led by an expert trainer Bob McDowall who has more than 50 years of experience in total and over 35 years of experience in automating laboratories and computerized systems. He always shares many valuable automation examples from the Pharma laboratory environment. He has put together key takeaways for all who are currently on their automation journey and here are some of them:

• You can’t automate the whole laboratory at once, it will take time
• Senior management support and resources are critical for success
• The key to digitalization success is to understand your current process and design activities to work electronically
• Annex 11 clause 1 requires risk management throughout the system life cycle

Join Bob McDowall & your industry peers to understand your current processes & how to automate them. Don’t just take our word for it; hear from those who have experienced our training firsthand: “The Pharma Lab Automation and Digitalization training was one of the most useful courses I have participated in in recent years. Communication with Fleming Events has been smooth from general inquiry to registration; they were prompt in answering my questions and were accommodating during the registration process. Course materials were provided on time and in a secure manner.” Niña Cortina, Co-Founder and Head of System Integration, LiVeritas Biosciences “The course allowed me to define the global picture for our lab digitalization strategy as well as define where to start and what are the pitfalls.” Karine Peron, Head of Global Lab Operations, Merck In an ever-increasing digital environment, computerized systems validation (CSV) becomes another top priority for pharmaceutical, biotech & medical devices companies. In many cases, reliability, data security, availability, and scalability represent great challenges. Additionally, many have turned to cloud technology for the tremendous benefits it offers. On the other hand, the challenges of operating and maintaining sophisticated internal systems are increasing exponentially. Together with an expert trainer Dr. Thierry Dietrich, we have selected the most challenging areas related to current CSV methods. Whether it’s the data integrity assurance or the use of cloud-based systems in GxP regulated context, our courses are designed for an advanced level of knowledge on selected issues:

Computerized Systems Validation & Data Integrity in Pharma & Biotech

Gain insights into:

• CSV considerations around data integrity
• Inspection trends around CSV and data integrity
• Requirements for e-signatures/biometric signatures
• Shifting to a data perspective
• Verification & testing methods

Pharma & Biotech CSV in the Cloud (IaaS/PaaS/SaaS)

18 & 19 October 2023, Amsterdam, Netherlands & Online Live Stream, 9:00 CEST – 17:00 CEST  Get familiar with:

• Cloud Definitions & Models
• Service Level & Quality Assurance Agreements
• Data Migration & Interfaces
• Physical & Logical Security in a GxP Cloud System
• IT Incident, Problem, and Change Management in a GxP Cloud Context

Due to the current technology progress and electronic systems implemented in clinical studies (including smartphones & wearables, AI, electronic data capture, and real-time review of clinical data), many new issues have emerged in clinical trials, so the companies and regulators shifted their focus to new approaches to ensure data integrity and compliance of electronic systems used in clinical trials. Understanding regulations – particularly the principles and intent of those regulations – and being able to apply them to new technology and processes in clinical trials, is critical to a company’s success. Novel approaches to safeguard data integrity and human subjects need to be considered. We have prepared a unique course that provides a practical & in-depth understanding of electronic systems and technologies used in clinical trials and brings clarifications on global regulation, requirements, compliance & quality concerns: Digital Quality in Clinical Trials 28 – 29 November 2023 in Amsterdam, Netherlands Become a professional in:

• Global regulations for electronic systems in clinical trials & DCT projects
• Digital revolution in clinical trials & GCP compliance
• Remote auditing
• eConsent strategy & key considerations for compliance
• Audit trails of systems

Embracing all these key topics by attending any of our courses.  Stay on top of your competition and create a healthier, more connected world.