Latest Courses/Speaking Events
2024 Schedule
November 12: "CMC Strategies to Accelerate Development Whilst Not Sacrificing Quality"
TIDES EUROPE: Oligonucleotide & Peptide Therapeutics
(Hamburg, Germany)
Her presentation delves into innovative Chemistry,
Manufacturing, and Controls (CMC) strategies aimed at expediting development
processes without compromising quality. It offers practical approaches for
maximizing efficiency in pharmaceutical development, regulatory compliance, and
manufacturing.
December 2 - 4: "Analytical Method Validation for Biologics, Biopharmaceuticals and
Other Therapeutic Products"
Complex processes yield complex products such as biologics. Biopharmaceuticals demand numerous, non-compendial, and sometimes complex QC test methods to confirm manufacturing consistency and product quality.
While the 15-hour 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.
2025 Schedule
January 6-9: “Pharmaceutical
Root Cause Analysis of Failures & Deviations - Developing an
Effective CAPA Strategy”
This class prepares attendees with the knowledge and
tools 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 those 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.
January 21-25: "Good Manufacturing Practices Training | cGMP Course”
This course examines the ‘why’ of cGMP principles along with valuable insights and examples that will assist attendees in their quality decision-making, as well as, demonstrating ways to make their present systems more effective.
It is designed as a workshop for those working with finished pharmaceuticals, biologicals, APIs and/or combination products. Attendees will focus on addressing cGMP regulations, gain insight on how to better structure their respective quality systems, and more effectively manage and facilitate a compliant, efficient and cost-effective pharmaceutical operation.
Febuary 25-27: “Implementing an FDA Compliant Stability Program”
Regulatory compliant deficiencies in stability program have resulted in clinical holds and market approval delays.
Pharmaceutical companies must invest in an effective and regulatory compliant stability program strategy that can meet both FDA and EMA requirements and expectations.
This course is for directors, managers, supervisors, project planners, analysts, and professional staff seeking to understand, develop or implement a regulatory compliant stability program for their pharmaceutical chemical drug or biologic product. It is designed to help attendees learn to design and implement a stability program that can meet global requirements and expectations.
Course participants will also learn how to effectively interpret stability data.
March 24 - 26: “Pharmaceutical Production Batch Record Review | Training”
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.
Interactive sessions are included for identifying reviewer
responsibilities, establishing good documentation practices, and writing procedures for the review process.
This course is for people responsible for reviewing and
auditing production batch records, and batch record deviation investigations in pharmaceutical production, QA, and compliance.
