Webinar ID:   ICT125

Product Quality Review – A Practical Approach towards Compliance

ON-DEMAND
  2 Hours

Categories:   Uncategorised,

Product Quality Review or Annual product review are the favorite documents by inspectors and QPs. PQR will have all information about the product. Any missing information or wrong information may lead to serious non-conformance. Here we will explain about how to practically prepare the PQR, how to evaluate the data, how to perform statistical analysis etc. Further we will discuss about common errors related to PQR so that, you will able to learn from someone’s errors.

Why You Should Attend:

  • During webinar, we will able to prepare, review and approve PQR in more efficient way.
  • This webinar will make you understand the requirements of PQR in line with different guidelines.
  • You will able to understand the expectations of FDA vs EUGMP with this PQR
  • Will have practical session for performing the statistical analysis.

Areas Covered in the Session :

  • Introduction and overview of Webinar subject
  • Expectations about PQR from different regulatory agencies, Specific requirement from WHO and FDA
  • Keys of PQR, Practical approach how to specify the information in the different keys of PQR. Grouping considerations in PQR
  • Performing statistical evaluation in PQR, a practical experience/example to perform calculations and evaluation of the results
  • Common Practical problems during PQR, Common non conformance in PQR, FDA citations and learning.
  • Discussion and Q&A/Queries

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Contract Manufacturing Organizations
  • Data Integrity Teams
  • Documentation Departments
  • Supply Chain Departments

ICT125

HitendraKumar Shah

Hitendrakumar Shah is a renown Quality oriented professional with over 20 years of experience in Quality Assurance and Quality Control. During this period, he has been actively involved in process control, Finished product release, Investigations, product recalls and other quality notifications. He has helped numerous companies in ensuring CAPA implementation & effectiveness, Quality system review and reporting, Supplier audit, GMP training, risk assessment and validation activities.

His Key Competencies are but not limited to Quality Compliance, Vendor Audit, data integrity, Risk assessment, Qualification & validation, Review and finalization of technical agreements. He is the CEO of NADH+ GxP Compliance Services and a popular figure on social media for his effective and easily understandable training bites.