In a cGMP environment, in order to effectively perform his/her work, one must be able to link science, regulations and practices. And Pharmalytik training program will provide such courses.
Interactive exercises, numerous real-life case studies, practical discussion scenarios are many ways that these courses will be structured to explain the scientific basis, the regulatory concerns and the practical way to meet all expectations.
Textbook "Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices" will be included in the course, as requested. This book is known as one of the practical reference sources and have been widely used by regulatory agencies and scientists worldwide. It also is used as textbook of Pharmaceutical Analyses course in the Professional Master Program of Illinois Institute of Technology and QA/RA Master Graduate Program of Temple University-School of Pharmacy.
Available On-Site Courses
- Stability Testing: ICH/FDA Regulations and Industry Best Practices
- Developing and Validating Stability Indicating Methods
- Design Stability Studies to Reduce Costs: Matrixing and Bracketing
- Developing and Validating Analytical Methods
- Stability Testing Performed Over A Product Lifecycle
- Assessment of Validation for Mature Pharmaceutical Drug Products
- Investigation of Out-of-Specs/Out-of-Trend for Stability Testing
- Building a Successful Partnership with CRO
On-Site Courses can be requested by email to Info@Pharmalytik.com.
Courses are customized to fit your organization