Pharmaceutical Process Performance Qualification Certificate Webinar

Webinar Overview

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

● This webinar on Pharmaceutical Process Performance Qualification Focuses on the practical application of the lifecycle approach to all stages of ppq 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 of process performance qualification cover case studies from the pharmaceutical and biotechnology sectors.

● Anyone who wants to become a Validation specialist/scientist/engineer, Validation Associates, Production Personnel, Technical team members, Management team members, Auditors, Consultants should attend this webinar on process performance qualification.

Course Offers

Pharmaceutical Process Performance Qualification

Webinar Module

Webinar 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

Instructor Profile

Dean Rathi Param

B.Sc., Post Grad Cert., in Pharma QA QC, (MBA/TECH)

She is an innovative and creative leader with more than twelve years of hands-on experience in many scientific industries, complemented with ten years of training/teaching experience.

Rathi Param is the president/founder of the North American College of Pharmaceutical Technology (NACPT) and ValidationTech Inc. She is an innovative and creative leader with more than twelve years of hands-on experience in many scientific industries (medical devices, environmental, food, pharmaceutical and biopharmaceutical), complemented with ten years of training/teaching experience. She possesses extensive expertise and knowledge of Quality Control, Quality Assurance, Validation, Technology Transfer, Manufacturing Technology, Process Improvements, Auditing and Inspection.

In the past twelve years, Rathi has held strategic management roles in major Canadian name brand/generic pharmaceutical companies. Validation Scientist at Patheon Inc., Validation Services Manager at Sanofi Pasteur Limited, Toronto., Validation Specialist at CibaVision, Toronto., and Validation Quality Engineer (Consultant) at iPOC, Toronto were few to be named.

Her interest in helping graduates to commence their careers in the pharmaceutical industry was the motivation to launch NACPT and Validation Tech, to provide hands-on training and create a platform to direct the pathway to successful recruitments by the pharmaceutical companies.

PHARMACEUTICAL PROCESS PERFORMANCE QUALIFICATION

Pharmaceutical Process Performance Qualification

Webinar Module

Learning Outcomes

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