Latest Courses/Speaking Events
Dec. 16-18: "Analytical Method Validation for Biologics, Biopharmaceuticals
and Other Therapeutic Products”
(On-Site or Live Stream)
Complex processes yielding complex products such as biologics and biopharmaceuticals demand numerous, non-compendial, and sometimes complex QC test methods to confirm manufacturing consistency and product quality. This course provides:
- A comprehensive overview of the international regulatory authority requirements and expectations for test method validation of these assays.
- 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 in biologic and biopharmaceutical companies.
- An overview of validation of QC analytical test methods (e.g., electrophoretic, HPLC, peptide mapping, etc.), cell-based potency bioassays, immunochemical binding impurity assays and adventitious agent assays.
Attendees will have a clear understanding of international regulatory authority regulations and gain background knowledge necessary to effectively plan and execute QC test method validation programs.
2026
SPEAKING AT TIDES May 11, 2026
"Quality and Regulatory Aspects of an IND"
Presentation and Panel Discussion
Judy’s presentation outlines key considerations and essential steps for establishing robust quality systems for oligonucleotide active pharmaceutical ingredients (APIs) and drug products (DPs), aligned with regulatory expectations.
As oligonucleotide therapeutics rapidly advance through innovations in chemistry and delivery technologies, ensuring the quality of both APIs and DPs is critical.
Attendees will gain insights into best practices for compliance and strategies to support the successful development and commercialization of oligonucleotide-based therapies.
May 19-21: “Implementing an FDA Compliant Stability Program”
(On-Site & Virtual)
Compliance failures* in stability testing programs can result 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.
*Here is an April 2026 Warning Letter noting
how one firm ” … failed to establish and follow
a written testing program designed to assess
the stability characteristics of drug products …”
June 1-4: "Good Manufacturing Practices Training | cGMP Course”
(On-Site or Live Stream)
This course examines the “Why” of cGMP principles. It also provides 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.
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.
June 16-18: "Analytical Method Validation for Biologics, Biopharmaceuticals, & Other Therapeutic Products" (On-Site or Live Stream)
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.
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.
July 13-16: “Pharmaceutical
Root Cause Analysis of Failures & 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.
Aug. 4-6: “Pharmaceutical Production Batch Record Review | Training”
(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.
Aug. 4-6: “Pharmaceutical Production Batch Record Review | Training”
(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.
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