Regulatory Streamline Approach for Design, Validation & Qualification of Pharmaceutical Manufacturing Facilities & Equipment Oral Solid Dosage Forms (21 CFR Part 211)
- 3 days (2 days can be customized)
- Course fee
- Validation and Qualification scientists, Supervisor and Manager
- Production supervisors or Manager
- Quality Department (QA), Regulatory Affairs and Compliance
- Engineering Department Staff (Maintenance, Project Management, Utilities Engineers)
- Professionals from service organizations and vendors who serve pharmaceutical clients
- Professionals from service organizations, contractors, designers, and vendors who provide services for pharmaceutical Industries/clients.
- Regulatory bodies involved in pharmaceutical industries.
- Internal/External Auditors and consultants.
Objectives and Expected Results
- Participants will understand the cGMP design Requirements needed for Facilities/Systems dedicated to Oral Solid Dosage forms manufacturing, processing, packaging, and storage.
- Participants will get an in-depth understanding of GMP key aspects that are related to cGMP utilities (Design versus facility functions) as well as cGMP construction, operation, and maintenance requirements.
- The participant will have knowledge of “how things work” and how this may help in cGMP Design, Engineering troubleshooting & fixing problems
- The participant will be familiar with Evaluation for the demands of the new production line to avoid over/underutilization
- Participants will have a good idea about the design requirement to prevent the contamination/cross-contamination between rooms/zones with different functions.
- Participants will have proper knowledge and considerations for all prerequisites that must be taken prior to Qualification & Validation of OSD equipment and Systems.
- Participants will take an idea of Qualification & Validation (Q&V) activities for different Equipment and System for OSD facilities
- The participant will understand the regulatory basics Design, Validation & Qualification and Engineering Requirements for OSD Facilities
- The participant will take an idea and differentiate between cGMP and non-cGMP layouts
- The participant will be able to make an evaluation for the acceptable and the best cGMP practices within each of his/her firm
- Participants will be familiar with cGMP design-related topics for European, US FDA and other international requirements expectations and how they are reflected and implemented on field
Others Training Materials
- Workshop, Sheets and case studies paper will be conducted and implemented during training
- Documentary Videos will be presented for OSD Equipment and systems, including Mixing, Blending, Drying, Sizing, Tableting, Encapsulating, and Coating that provides participants with a visual demonstration of current manufacturing and engineering practices.
Trainer Languages English/Arabic