Latest Courses/Speaking Events
2026
Does your test method validation package stand up to FDA scrutiny?
Sept. 15-17: "Analytical Method Validation for Biologics, Biopharmaceuticals,
and
Other Therapeutic Products"
(On-Site or Live Stream)
Complex processes yield complex products along with complex QC test methods to confirm manufacturing consistency and product quality.
The course focuses on examples of test method validation for biologics and biopharmaceuticals.
And the principles and practices are universal for all therapeutic pharmaceutical products.
Is your CAPA Program ready for regulatory review?
Oct. 19 – 22: “Pharmaceutical Root Cause Analysis of Failures and Deviations – Developing an Effective CAPA Strategy”
(On-site or Live Stream)
This class prepares attendees to plan and execute test method validation packages for the NDA, BLA and MAA market application dossiers,
covering in-process, release and stability assays commonly used by QC.
It is designed for people who perform, supervise, manage, audit, or oversee validation of test methods
for the QC of biologic and biopharmaceutical products.
While the course focuses on test method examples for biologics and biopharmaceuticals, the principles and practices of
test method validation taught in this course are universal for all therapeutic pharmaceutical products.
Nov. 3-5: "Pharmaceutical Production Batch Record Review | Training"
(On-Site or Live Stream)
(On-Site or Live Stream)
This course takes the mystery out of the batch record review process.
The class examines the FDA and EU regulatory requirements for documentation and batch record reviews, explains the elements of the batch record review process, and clarifies the pathway to effective deviation investigations.
This course is for people responsible for reviewing and auditing production batch records, and batch record deviation investigations in pharmaceutical production, QA, and compliance. Interactive sessions include identifying reviewer responsibilities, establishing good documentation practices, and writing procedures for the review process.
Need more insights into GMP concepts and how to apply them when it counts?
Dec. 1-4: "Good Manufacturing
Practices Training | cGMP Course"
(On-Site or Live Stream)
Examine the "Why" of cGMP principles
This course provides valuable insights and examples that assist attendees in their quality decision-making, as well as demonstrating ways to make their present systems more effective.
Designed for people working with finished pharmaceuticals, biologicals, APIs and/or combination products, this workshop will focus on addressing cGMP regulations, gain insight on how to better structure quality systems, and effectively manage and facilitate a compliant, efficient and cost-effective pharmaceutical operation.
