APPLY NOW
Certificate

Pharmaceutical Process Performance Qualification

Process Validation (PV) is a critical element in the pharmaceutical manufacturing process. Hence experts in this domain are in high demand.

This training program focuses on the practical application of the lifecycle approach to all stages of process performance qualification to gain appropriate levels of knowledge and insight on the regulations, guidance, and best practices currently utilized across the industry. The modules on this subject cover case studies from the pharmaceutical and biotechnology sectors.

Program Offers

  • Register for 3 certificate programs at NACPT and get any available 1-day training for free.
  • Attendees will be issued the certificate of completion at the end of training program.

Program code:

Credential:

Certificate

Duration:

Delivery Mode:

Online / Onsite / Recorded Program

Start Date(s):

Apply Now

Learning Outcomes

After successful completion of this course, students will be:

  • Able to understand current Lifecycle Process Validation (PV) approach
  • Benefits of process validation
  • Select and implement different types of process validation
  • Able to write protocols and validation plans
  • Able to perform risk analysis
  • Able to perform continuous process improvements

Program Module

  • Module 1
    • Pharmaceutical Process Validation/Cannabis Process Performance
    • Process Performance Qualification Objectives
  • Module 2
    • Process validation stages
    • Process validation approaches
    • Process validation components
  • Module 3
    • Master Validation Plan
    • Process Validation Strategy
  • Module 4
    • Preparing for Process Performance Qualification (PPQ)
    • Sampling plan and testing plan
  • Module 5
    • Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement
    • Understand implications of validation deviations
    • Minimize the chance of validation failures
    • Acquire tools to prepare for a smooth validation execution
  • Module 6
    • PPQ for Bulk Hold Time Studies
    • PPQ for Stability Studies
    • Process Controls
  • Module 7
    • Case Study – Pharmaceutical Process
    • Case Study – Biotechnology Process

Who Should Attend

Anyone who wants to become the following should attend this webinar on pharma cleaning validation:

  • Validation Specialist / Scientist / Engineer
  • Validation Associates
  • Production Personnel
  • Technical Team Members
  • Management Teams
  • Auditors
  • Consultants
  • Validation Assistant
  • Process Validation Specialists
  • Coordinators
  • Managers