Regulation, Quality and Compliance in ADC Manufacturing

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Course Overview

This course provides a practical understanding of data technologies used in clinical trials and is intended to provide attendees with the latest regulations, guidelines and requirements for using electronic data in clinical trials. With the recent widening of the guidelines and regulations to encompass electronic data, it is essential that all persons involved in any aspects of clinical trial data understand the principles and intent of the regulations. Companies must ensure that the QMS processes used in the management of clinical trials fully cover all areas of the regulations in relation to the management and integrity of clinical trial data.

Join us for an immersive two-day webinar on “Regulation, Quality and Compliance in ADC Manufacturing,” designed to equip professionals with essential knowledge and skills in ADC production. Delve into the complexities of Antibody-Drug Conjugates (ADCs) and gain insights into their mechanisms of action. Understand the intricate regulatory landscape and stay ahead with the latest compliance requirements. Learn about Good Manufacturing Practice (GMP) and Quality by Design (QbD) principles tailored specifically for ADCs. Enhance your skills in managing change and technology transfer processes in ADC manufacturing. Tackle real-world manufacturing challenges with expert-led interactive workshops. Connect with industry leaders and peers to exchange knowledge and best practices. Earn a certification that validates your expertise and advances your professional qualifications. Don’t miss this opportunity to deepen your understanding and ensure excellence in ADC manufacturing.

Key Topics:

Introduction to ADCs, Mechanism of Action and Regulatory Landscape

Good Manufacturing Practice and Quality by Design (QbD) in ADCs

Change Management and Tech Transfer for ADCs

GMP ADC Manufacturing: Key Steps and Technical Challenges

Critical Control Points for CMC Compliance in ADCs

Workshop on ADC Manufacturing Challenges and Solutions

Trainer Profile

Dr. Felix Kern

Associate Director
Merck KGaA

Dr. Felix Kern is the Associate Director (Head of Compliance) at the Launch Center of Merck KGaA in Darmstadt. He studied pharmacy in Mainz and earned his doctorate at Ludwig Maximilian University of Munich. He is a specialist pharmacist in Pharmaceutical Analytics and Pharmaceutical Technology. Over the past nine years, he has worked as a QA Manager at a global medical and combination products company and as a Production Manager in bulk tablet manufacturing. Additionally, he has given numerous foundational lectures on GMP, quality, risk management, and pharmaceutical and medical device regulations.

Course Features

Real-Life Case

Courses with real-life case studies and best practices

Renowned Trainers

Best in class and renowned trainers

Certificate

Certificate of completion issued by the trainer

Interactive sessions

Interactive sessions that go beyond traditional lectures

Benefits

Enhance the knowledge, skills, and competencies of your team in the Industry sector: Our curriculum is meticulously crafted to elevate your team's expertise in the industry, equipping them with the tools they need to excel.
Courses curated with real-life case studies: Dive into practical applications with our curated selection of real-life case studies, providing invaluable insights and hands-on learning experiences.
Certificate of attendance: Upon completion of the course, participants receive a certificate of attendance, validating their commitment to professional development and mastery of the subject matter.
Learn from well-reputed and experienced trainers with over 25 years of expertise: Benefit from the wealth of knowledge and experience offered by our esteemed trainers, each boasting over 25 years of industry experience.
Highly interactive and informative sessions: Engage in lively discussions, interactive exercises, and dynamic activities designed to enhance learning and retention. Our sessions are tailored to foster collaboration, critical thinking, and skill application.
Cost-effective yet result-oriented: We understand the importance of maximizing your training budget. That's why our courses offer exceptional value without compromising on quality. Achieve tangible results and measurable outcomes that drive success for your team and organization.

Course Price

Discounted Price €1,259

€1,399

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