Pharmaceutical Process Performance Qualification

Live Session

Certificate Awarded: Process Performance Qualification – Certificate
Level of Training: Beginner | Intermediate
Mode of Delivery: Online / Onsite / Recorded Program
Fee: $960

Both Online and OnCampus training is available

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Program Overview

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.

Additional Program Info

Program Module
Learning Outcomes
Job Opportunities
Who Should Attend

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

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

Job Opportunities

Validation Assistant
Process Validation Specialists
Coordinators
Managers

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

Faculty of Pharmaceutical Process Performance Qualification

Rathi Param

President / Founder & Dean

– B.Sc., Post Graduate Pharma QA & QC, MBA / TECH

Rathi Param is the president/founder of NACPT Pharma College, International Medical Cannabis Association (IMCA), and Validation Tech Inc. Rathi earned her B.Sc. in Chemistry from University Ottawa, MBA in Technology from the University of Phoenix and Post Graduate Pharmaceutical QA & QC Certification from SRN Institute. She is an innovative and creative leader with more than twenty years of hands-on experience in many scientific industries (medical cannabis, medical devices, environmental, food, pharmaceutical and bio-pharmaceutical), complemented with fifteen years of academic and corporate training experience. She possesses extensive expertise and knowledge of Quality Control, Quality Assurance, Formulation, Validation, Technology Transfer, Manufacturing Technology, Process Improvements, Auditing, and Inspection.

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