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 are 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 online course focuses on the fundamentals of each discrete processing step (unit operation) required for the manufacture and packaging of tablets and capsules.
This online course covers pharmaceutical facilities for the manufacture of OSD forms, including tablets, capsules, and general powders. It also may be applied to pilot and clinical supply facilities. The eLearning course is not intended to address the manufacture of dietary supplements, excipients, sterile products, topicals, oral liquids, or aerosols. Wherever applicable, references are provided to existing Baseline® Guides for further detail on specific systems or operations.
Immediately apply the course learning objectives with an electronic download of the ISPE Baseline® Guide:Oral Solid Dosage Forms, 3rd Edition.
Attendance suggested for:
- New pharmaceutical oral solid dosage professionals or those working in Quality Assurance, Operations, Logistics, Commissioning / Qualification / Validation and Equipment Suppliers, Architects, Engineers, and Regulatory Professionals.
- Those with significant pharmaceutical industry experience who now have solid dosage responsibilities and want to gain a fundamental understanding of unit operations and equipment used to manufacture, package, and test solid dosage products.
Course Modules/Learning Objectives
- Module 1: Regulatory Philosophy
- Understand guidance on regulatory expectations as it is applied to the design of Oral Solid Dosage (OSD) process systems and facilities.
- Provide guidance on the principles for establishing an effective Quality Risk Management Process.
- Module 2: Equipment Considerations
- Understand aspects of technologies, unit operations, and associated equipment pertinent to product quality and facility design.
- Module 3: Product Isolation and Containment
- Describe containment considerations for OSD manufacturing.
- Module 4: Architectural
- Understand the requirements for architectural design considerations.
Dave DiProspero has 25 years of Pharmaceutical Engineering experience with a specialty in Oral Solid Dose Form (OSD) manufacturing operations/facilities/equipment and technology. His primary expertise is in Internationally regulated cGMP manufacturing operations with an engineering, process, containment, equipment, material handling and facility integration background. He is experienced in master/capital planning, conceptual/preliminary/detailed design and engineering, procurement, qualification and project management related to FDA 21-CFR Part 210 & 211, EU Volume 4 and other international pharma regulations.
Dave has worked as an owners-representative as well as direct employee for pharmaceutical equipment/technology suppliers and engineering firms. He is currently an Associate/Director of Pharmaceutical Process Technology for CRB (Top Ranked Pharma Professional Services Firm). He provides project oversight and professional consultation, project implementation/execution and is an experienced team communicator/facilitator.
Dave has worked as an owners-representative as well as direct employee for pharmaceutical equipment/technology suppliers and engineering firms. He is currently a Sr. Pharmaceutical Specialist for CRB (Top Ranked Pharma Professional Services Firm). He provides project oversight and professional consultation, project implementation/execution and am an experienced team communicator/facilitator.