On Site Short Courses

Offered Courses

Regulatory

Good Manufacturing Practice Regulations: 21 CFR 210-211 (one day)
Introduction to the Regulatory Process and GMP Regulations for Drug Development and Manufacturing (three days)
Introduction to the Drug Regulatory Process: INDs, NDAs and ANDAs

cGMPs for Pharmaceutical QC/R&D Laboratories: Improving Performance and Efficiency with GMP Compliance
Understanding the Good Clinical Practice (GCP) Regulations (one or two days)

Clinical/Pre-clinical

An Introduction to Pharmacokinetics
Applied Pharmacokinetics (intermediate level)
Basic Pharmacology
Cardiovascular Physiology and Pharmacology

Research Design

Basic Statistics and Practical Pharmaceutical Applications
Pharmaceutical Experimental Design
Pharmaceutical Experimental Design and Applied Basic Statistics (four and one-half days)
An Introduction to the Use of Minitab Software and Applications for the Pharmaceutical Industry
Principles of Sampling for Solids, Liquids, and Gases (one-day)

R&D/Manufacturing/Quality Control

Current Issues and Challenges of Dissolution
HPLC Method Development: An Interactive Course
Statistical Tools Supporting Quality Risk Management and Analysis (ICH Q9) (one day)
Pharmaceutical Data and Analysis in a Regulatory Environment (one day)
Avoiding and Correcting HPLC Problems when Transferring Methods
Physical and Chemical Characterization of Drug Substances in the Pharmaceutical Industry
Practical Applications for Pharmaceutical Analysis in Product Development
Stability of Pharmaceuticals (three days)
Identifying and Handling Out-of-Specification Results (one-day)
Pharmaceutical Systems-Based Management: Strategies for GMP Compliance
Fundamental Aspects of Solid Dosage Forms
Cleaning Validation (under development)
Water in Pharmaceuticals (two and one-half days)

Other programs as needed, can be developed to meet specific needs within a company.

General Information

Enrollment

Enrollment is restricted to 25 students to insure maximum learning and interaction with faculty.

Registration Fees

One fee includes course development/coordination, faculty honoraria/expenses and the printing/shipping of course materials. The only expense to pharmaceutical companies would be the meeting room, audiovisual equipment and any necessary refreshments.

Companies/Organizations where UW On-site Short Courses have been presented in the Past Three Years

Amgen, Inc.
Astellas
Bristol-Myer Squibb

CIMA Labs Inc.

Covance Laboratories
Ecolabs
Elan Pharmaceuticals

Forest Research Institute
GlaxoSmithKline

Health Canada
Johnson and Johnson
Merck, Inc.
NASA
Ortho McNeil
Penwest Pharmaceuticals
Pfizer, Inc.
PPD
Sepracor, Inc.
Schwarz Pharma
Solvay Pharmaceuticals
Transform Pharmaceuticals
United States Pharmacopeia

Vertex Pharmaceuticals

Wyeth Consumer Healthcare
Xcelience LLC

For More Information

Dr. James E. De Muth
777 Highland Avenue
Madison, WI 53705
(608) 262-2422
FAX (608) 262-2431
Send Email

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ON-SITE CONTINUING EDUCATION PROGRAMS

Short Courses for the Pharmaceutical Industry