Events (Block Dates)

This course is designed to expose participants to a variety of topics, including: biopharmaceutical product development, biomanufacturing strategies, the various types of products and their applications, the current requirements for CGMP manufacturing of biopharmaceutical products and how to plan for CGMP implementation in your facility, how to maintain a state of control during biomanufacturing, bulk plant design from a process/product perspective, architectural considerations and facility layout, and cleanroom requirements.

This course is designed to teach students the techniques for effective qualification and validation of sterile drug product manufacturing systems.

This course will be geared towards individuals that have input to; oversight for; or actively participate on; drug delivery combination product development teams.

The two-day workshop will offer insight into the science of glass and its inherent properties.

This class looks at DoE strategy and introduces more advancedtechniques for both understanding variation and demonstrating that the commercial process is capable of producing quality product.

This conference will cover a broad variety of essential biological raw materials for cell-based medicinal products such as human platelet lysate or other serum replacements and materials from recombinant cell cultures such as cytokines.

This course will provide a practical and detailed overview on how to consistently perform risk-based analytical method qualification and validation for all method and product lifecycle steps.

This course will review the regulatory challenges from a Chemistry, Manufacturing & Control (CMC) perspective of biosimilars.

The Future in Injectables

This course will provide practical guidance of key aspects laid down in the ICH Q7 guideline. It will clarify and layout the appropriate GMP standard to be applied by API manufacturers.

Discounts apply when you register for more than one course.

As statistics is the "Science of Variation", this two day course presents basic concepts within a cGMP framework using the analytical and manufacturing tools of our environment.

Discounts apply when you register for more than one course.

The course will focus on how to recognize biases/errors made in the estimation of severity and the probability of a failure and on how to reduce their influence so that more accurate estimations of severity and probability are obtained.

This course discusses process design, evaluation and management, risk and root cause analysis, quality costs and quality metrics, promotion of quality, strategic quality planning, design of a user-friendly documentation system, change management and other skills.

This course will help the participants select the appropriate quality metrics, determine how best to collect the data and how to use the data to improve the quality system.

In eight sessions, a broad range of manufacturing aspects will be presented, covering primary packaging components and devices, Blow-Fill-Seal Technology and isolators, fill-finishing operations and freeze-drying, final product testing, labelling and secondary packaging, logistics and good distribution practices. The presentations will address new technologies but also include the latest regulatory and pharmacopoeial requirements.

This course is designed to present the critical support elements of investigations, including quality culture, integration of quality risk management and continuous improvement.

This course will provide detailed guidance for application and implementation of quality risk management principles throughout the product lifecycle, with emphasis on quality risk management application during commercial manufacturing, and integrating quality risk management into the pharmaceutical quality system.

This course has been canceled due to unforeseen circumstances and will not be rescheduled.