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Starting May 2022
2-day live online training course
Starting May 2022

2-day live online training course

UNDERSTAND CURRENT AND EMERGING EXPECTATIONS FOR CMC ANALYTICAL STUDIES TO ALIGN WITH REGULATORS AND EXPEDITE THE DEVELOPMENT OF ALL TYPES OF BIOLOGICAL PRODUCTS

Critical-path analytical studies for Accelerated, Breakthrough and Biosimilar Products

Course Overview

This course will provide attendees with a concise but comprehensive overview of all relevant regulatory, technical, and quality elements necessary to assure successful planning and documentation of the required CMC analytical and stability studies for biological products. Key data deliverables from each phase of development will be illustrated. Current ‘hot-button’ CMC analytical and stability issues will be presented, and strategies for preventing (or remediating) gaps will be presented, based on real-world experiences of Dr. Nadine Ritter supporting hundreds of biological products over more than 25 years.

What will you learn?

Phase-specific requirements

Gain a comprehensive overview of the current and emerging regulatory guidances that govern the phase-specific requirements for CMC analytical studies with any type of biological product

Critical path studies

See the rationale behind the critical path analytical CMC studies required throughout different stages of the product life cycle including pre-clinical, clinical trials, commercialization, and post-approval to make effective timeline decisions

Product specifications

Understand the rationale behind setting meaningful, supportable product specifications; learn the key elements to include in biological product analytical control strategies

Method lifecycles

Review the applicable regulations that define phase-specific method validation expectations, and learn best practices for analytical method qualification, validation, verification, tech transfer, and method bridging for all types of methods for biological products.

R&D to GxP Quality Practices

Understand the specific laboratory operational requirements for GxP compliance during product development, and learn the emerging expectations for lab quality and data integrity in R&D labs that generate the CMC data submitted in product dossiers

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.

Over 2 days students will learn through:

  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • Revisiting recorded sessions with unlimited access for 30 days
  • Interaction with peers during live sessions and through the online forum

Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact lifesciences-training@informa.com.

Who is this course for?

This training course is intended for professionals who are involved with stability testing for biotechnology products, directly or indirectly. Professionals from Pharmaceutical, Biotechnology, Drug Delivery and Medical Device companies should attend, such as, but not limited to:

  •  Stability Directors/ Supervisors/Managers/Analysts/Coordinators
  • Laboratory Supervisors/ Managers
  • Project Managers/Coordinators
  • Quality Control Analytical Chemists
  • Research and Development Chemists
  • Biostatisticians
  • LIMS Administrators
  • QA/QC Reviewers
  • Validation Scientists
  • Calibration/Metrology Groups
  • Internal or Independent Auditors
  • Manufacturing/Production Managers

The analytical side of CMC with course leader, Nadine Ritter

Nadine Ritter, President and Analytical Advisor at Global Biotech Experts, discusses how shortening timelines are impacting the analytical side of chemistry, manufacturing, and control (CMC).

Analytical Development

Manager

Rottapharm Biotech

Nadine was really clear, it is evident that she really knows the object of this course. By using examples, she made everything really easy to understand.

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.