Age: 48

Gender: Female

Occupation: Director of Quality Assurance and Compliance, Pharmaceuticals Manufacturing Plant Europe HQ Branch Office, EU Regional Compliance Lead Pharma Division of multinational entity (Global Compliance team member). Experience includes direct management of cross-functional internal audit teams for GMP quality compliance for drug products and devices at various sites globally including North and Latin America, Europe, Middle East, Asia Pacific and Oceania. Focus is on quality program execution ensuring high standards for regulatory and patient protection are maintained through inspection readiness and post-approval product quality and regulatory compliance activities. Performs root cause analysis for complex investigations, and oversees implementation of corrective and preventive actions (CAPAs) to prevent recurrence and assure continuous improvement culture regarding high ethical values and compliance to standards. Experience leading global virtual teams and onsite/offsite meetings during both regular business and during crisis situations and remediation efforts including global product recalls. Responsibilities include risk assessment for proposed actions including mitigation and risk communication to executive leadership. Leadership experience includes coaching and mentoring staff for success. Excellent leadership and communication skills with ability to interact in cross-functional teams, with external regulatory agencies, and with executive management. Background includes experience managing budgets, forecasting revenue and expenses, reviewing complex contracts, and developing business plans. Expertise includes thorough working knowledge and interpretation of worldwide regulatory standards including GMP, GLP, GCP and ICH guidelines and compliance standards. Direct interactions with regulatory agencies and notified bodies, including successful outcomes during routine and for-cause inspections. Extensive experience developing policies, procedures, and training programs to ensure successful compliance performance. Serves as mentor to junior colleagues during their professional development, in addition to their technical contributions and subject matter expertise to the pharmaceutical sciences, clinical pharmacology, and drug safety industries. Background includes teaching at university, serving on dissertation committees, mentoring doctoral students, authoring scientific papers and book chapters, and presenting research findings at scientific conferences. She also has volunteered for several charitable organizations. She also has published several well known books with international distribution and high popularity as college textbook references in the drug development industry. And is also the recipient of the prestigious lifetime achievement award from the Parenteral Drug Association (PDA), a nonprofit organization dedicated to advancing pharmaceutical science and technology. Awarded for over 25 years of career service to the biopharmaceutical manufacturing industry providing quality risk management (QRM) and sterile process technical expertise, including significant contributions to the development of several groundbreaking GMP technical reports with PDA as subject matter expert on behalf of pharmaceutical manufacturers. She is the main decision maker regarding investment and implementation of new AI-Powered solutions for the company.

Education: Doctorate Degree, Pharmaceutical Sciences

Age: 52

Gender: Male

Occupation: Senior Director of Production, Head of Process Optimization Initiatives for Biotech Manufacturing, CDMO based in the United States. He is primarily responsible for leading the efforts to improve process control and monitoring. He drives the adoption of advanced technologies in the manufacturing processes. He is also in charge of leading the process development teams and helping with scale-up and tech transfer activities. His company is looking for AI and machine learning tools that can automate their batch record review processes. The software tool must integrate with their existing IT infrastructure. He is also tasked to reduce the amount of time it takes for scientists to analyze manufacturing data. As a departmental head he is very budget-conscious and expects to see a clear ROI with any new technology investments. He is keen on AI solutions as he expects a long-term impact on his team and the company. He often reads industry reports and attends virtual seminars on the use of AI in biomanufacturing. He is looking to digitize the paper-based batch records to enhance data integrity and to streamline audit readiness for any future regulatory inspections. As an active executive board member he ensures collaboration with internal stakeholders such as quality assurance, regulatory affairs, and IT. He is also the main decision maker regarding investment and implementation of new AI-Powered solutions for the company.

Education: Master's Degree, Chemical Engineering

Age: 45

Gender: Male

Occupation: Head of TechOps and Digital Transformation, Responsible for all technology and operations management within the company. He leads the digital transformation initiatives across the organization. He is heavily involved with the strategic investment plan for implementing AI solutions. He is also in charge of the technology budget, managing external vendors, and planning for future technological needs and upgrades. Raj works very closely with the operations team to deploy and support new technology solutions, and he is responsible for technology compliance and data governance and making sure all systems adhere to regulatory requirements. He works very closely with cross-functional teams to ensure successful project outcomes and system integrations. With a background in computer science and information systems Raj likes the hands-on approach to technical challenges. He attends industry conferences and reads technical whitepapers to stay updated with the latest trends in AI and machine learning. He seeks solutions that not only resolve immediate challenges but also contribute to long-term sustainability. He values vendors that can provide comprehensive support and training for his team. He oversees the technical infrastructure required for AI-powered manufacturing solutions. He is also the main decision maker regarding investment and implementation of new AI-Powered solutions for the company.

Education: Master's Degree, Information Technology