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
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