Type: Classroom Training Course
ISPE CEUs: 1.3
|25-26 February 2013||Tampa, Florida||USA||Jack Chu|
|14-15 May 2013||Indianapolis, Indiana||USA||Jack Chu|
|22-23 May 2013||Brussels||Belgium||Rob Walker|
|11-12 September 2013||Burlingame, California||USA||Jack Chu|
Oral Solid dosage forms (Tablets and Capsules) are some of the most popular and convenient methods of drug delivery. They can be produced in a non-sterile environment and the process, equipment and technology is well defined and known, after more than 100 years of development.
With the high volume of products produced in these dosage forms, it is important that the unit operations for their production be thoroughly understood. This course focuses on the fundamentals of each discrete processing step (unit operation) required for the manufacture and packaging of tablets and capsules.
The course will begin with a description of the three main OSD processing methods: Direct Compression, Wet Granulation and Dry Granulation. It will continue with a detailed review of all the major unit operations associated with OSD manufacturing processes. This includes: Ingredient Dispensing/Formulation; Blending; Granulation; Drying; Compression/Encapsulation; Coating; Packaging and Miscellaneous Operations.
The course will focus on the process, equipment and technology associated with the unit operation, giving the attendee a general understanding of the OSD process and many of the issues, considerations and related concerns. The specific types of equipment and technology used in today’s modern manufacturing processes will be discussed and attendees will gain an appreciation for the selection and evaluation of such criteria. For example, a discussion of granulation will include information on different types of granulators (low shear, high shear, top drive, bottom drive, integrated processing trains) and typical challenges encountered during operation and scale-up.
A variety of process monitoring techniques will also be discussed. The course will review many known techniques for process monitoring with particular emphasis on their utilization in scale-up and technology transfer, final dosage unit and analyze the necessary steps in the packaging operation to get from the finished tablet or capsule to the final filled and sealed container. Introduction to packaging equipment for tablet/capsule counting, capping, security seals and bands, labeling, cartoning, and blister packaging will also occur. The course will conclude with a discussion on technology transfer, how to get the product from the R&D laboratory to full-scale manufacturing, and how to transfer a marketed product from one facility to another. A competency test will be administered upon course completion.
Immediately apply the course learning objectives with the complimentary copy of the ISPE Baseline Guide®: Oral Solid Dosage Forms.
This course contains knowledge related to the CPIP™ technical knowledge competency elements Production Systems: Production Unit Operations - Drug (small molecule) and Biologics and Product Development: Formulation, clinical phases and manufacture. For complete information concerning the knowledge elements or the CPIP Credential, please visit www.ISPE-PCC.org.
This training course is of particular interest to existing and future members of the ISPE Oral Solid Dosage Community of Practice (COP).
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.