Regulatory Streamline Approach for Design, Validation & Qualification of Pharmaceutical Manufacturing Facilities & Equipment Oral Solid Dosage Forms (21 CFR Part 211)

Engineering and Validation

Operations

Quality

Target Level

• 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.

Description

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

Participants will be able to harmonize international regulation versus fieldwork.

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.

Target group