Latest Courses/Speaking Events
2024 Schedule
May 1 - 3: "Analytical Method Validation for Biologics, Biopharmaceuticals and
Other Therapeutic Products"
Complex processes yielding 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.
May 14 Workshop: "CMC and Nonclinical Strategies for an Oligonucleotide Phase1 IND"
Workshop Agenda (1:30 – 5:00 pm)
Opening Remarks
“Nonclinical Aspects of an IND” – Peter Korytko, Ph.D.
“Manufacturing Aspects of an IND” – Kathryn Ackley, Ph.D.
“Quality and Regulatory Aspects of an IND” – Judy Carmody, Ph.D.
Panel Discussion
June 4 - 7: “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.
June 25 - 27: “Implementing an FDA Compliant Stability Program”
It is important for a pharmaceutical company to have an effective and regulatory compliant stability program strategy that can meet both FDA and EMA requirements and expectations. Regulatory compliant deficiencies in stability program have resulted in clinical holds and market approval delays.
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.
July 15 - 18: "Good Manufacturing Practices Training | GMP 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.
August 12 - 14, 2024: “Pharmaceutical Production Batch Record Review | Training”
Take 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.
For pharmaceutical production, quality assurance and compliance personnel responsible for the review and audit of production batch records, and batch record deviation investigations.
August 12 - 14, 2024: “Pharmaceutical Production Batch Record Review | Training”
Take 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.
For pharmaceutical production, quality assurance and compliance personnel responsible for the review and audit of production batch records, and batch record deviation investigations.
July 15 - 18: "Good Manufacturing Practices Training | GMP 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.
