Building Validation and Qualification Master Plan (VMP/QMP)

Engineering and Validation

Operations

Quality

Target Level

• Validation and Qualification scientists, Supervisor and Manager
• Quality Senior Management
• Project Management Team
• Quality Department (QA), Regulatory Affairs and Compliance
• 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.
• IT Staff

Description

Objectives and Expected Results

• The trainee will understand the regulatory basics of the QMP.
• Participants will be familiar with European, PIC/s and US FDA requirements and expectations
• Participants will be able to harmonize international regulation versus fieldwork
• Participants will take idea how to incorporate the Risk Assessment with Qualification Master Plan during different project phases (i.e. URS, Risk Assessment, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ and Requalification)
• Participants will take an idea of how to build the QMP/VMP based on a targeted market and specific regulatory requirements.
• Participants will make an evaluation for the current QMP/VMP within his/her firm
• Participants will be able to handle VMP/QMP during different project phases.

Others Training Materials

Workshop, Sheets, and case studies paper will be conducted and implemented during training.

Target group