This 6-hr training will examine the analytical tools used throughout a drug product life cycle. There is a broad range of assays and techniques used to measure the quality, safety and efficacy of a drug substance or a drug product.

The training will challenge attendees to give thoughtful evaluation of their current strategies or to develop strategies from the ground up. The CFR regulations and guidance from the USP and ICH will be used as references and in support of creating a sound approach to the validation of analytical procedures for drug substances and products.

Learning Objectives:

• To grasp the importance of procedure selection
• To understand the purpose of establishing sound approaches to understanding the quality attributes of a drug substance or a drug product.
• To gain an understanding of the necessary relationship between GLP and GMP.
• To understand the pitfalls and risks of incomplete or non-robust validation.
• To strengthen understanding of the importance of upfront work.

• Review of procedures used in assessing quality, safety and efficacy of drug products.
• ICH and USP guidelines for procedure validation.
• ICH guidelines and Good Manufacturing Practice (GMP).
• Good Laboratory Practice (GLP).
• Phases of clinical trials and the path to commercialization.
• Key aspects involved in procedure validation.
• Complex procedures.
• Laboratory responsibility to assuring validation is robust.

Agenda: (All time in EST)

• 10.00am to 12.00Noon (Session 1)
• 12.00 Noon to 1.00pm (Lunch)
• 1.00pm to 3.00pm (Session 2)
• 3.00pm to 3.15pm (Break)
• 3.15pm to 5.00 (final session)
• 5.00pm onwards Q&A

This webinar will provide valuable assistance to personnel in

• All QC functions
• QC validation or technical transfer groups
• Commercial testing facilities
• Contract laboratory testing facilities
• Project support functions

Barbara Berglund, has been working in the pharmaceutical industry, specifically with sterile parenteral dugs, for over 10 years. Her experience includes her current role as a QC Manager as well as roles in the laboratory, project management, and clinical trial manufacturing.

The QC group she manages is directly responsible for method transfer and validation activities in support of contract manufacturing clients. She has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and Pharmacological and Physiological Science. She received her PMP certification in 2007 and her Green Belt certification in 2008.

Topic Background:

For the pharmaceutical industry, there are regulations governing testing the quality, safety and efficacy of a drug product to be used in people. The Code of Federal Regulations (CFR) governs what must be in place prior to testing a marketed pharmaceutical product. 21 CFR 211 provides the regulations for a GMP laboratory testing finished pharmaceuticals. The International Council on Harmonisation (ICH) and the United States Pharmacopeia (USP) give excellent guidance on the processes of verifications and validations.

Throughout the lifecycle of a product, analytical procedures may change. For example, the tools used to evaluate a drug substance may differ from those used to evaluate a drug product. A drug product may have more than one application, meaning differing concentrations, formulations and presentations. There may be solid dosage forms, parenteral liquid dosage forms, tablets, nasal sprays, devices or topicals. A single product may have a lifecycle spanning decades from innovation through commercial manufacturing. The procedures change, as do the formulations and uses. Advancing through the lifecycle, regulatory requirements change based upon phase and end use.

Validation of these analytical procedures may occur at any point during a product’s lifecycle. In general, procedure validation occurs when the end use of a drug product has been largely determined, which is typically around Phase II of clinical trials. At this time, enough is generally known about the drug substance and drug product based upon development reports, understanding of the processes, understanding of the product, and knowledge of the final product presentation to go forward with validation.

21 CFR 211 indicates agency expectations for procedure use in drug substances and drug products; 21 CFR 58 indicates agency expectations for Good Laboratory Practices. The ICH gives strong guidance as to how to approach validation; in addition, application of a sound, scientific approach to understanding the need and then applying rationale will result in robust procedure validations.

Registration - Session Only: $699.00

CD Recording Only: $1,099.00