Pharmaceutical Quality System (PQS)

Pharmaceutical Quality System (PQS), Product Quality Review, Change Mangement, Deviation and CAPA, OOS and OOT, Training
What you'll learn:
Developing the quality skills,You will able to understand quality requirements
What are the elements of pharmaceutical quality systems
Common key questions and answers related to PQS
Product Quality Review and many more
Change mangement, deviation and CAPA
Out of specification and out of trend
Requirements:
The person should be full focussed during the session.
Description:
This course consists of a total of 7 sections.Section 1 - Developing the training strategy for pharmaceuticals. This section will focus on training requirements for pharmaceuticals.Section 2 - Product Quality Review (PQR) – This section will primarily focus on product quality review or annual product quality review requirements as per ICH Q10, WHO, EUGMP, and FDA guidelines. The content of this section is as below.• Expectations about PQR from different regulatory agencies• Specific key expectations from regulatory guides (FDA, WHO)• Elements of Product Quality Review• Practical approach towards each element• Role of statistical evaluation in PQR• Practical examples for a detailed understanding of statistical evaluations• Broad Difference in expectations between EU and FDA• Common non-conformance identified in PQRIn this same section of PQR, there is one more lecture for key questions and answers related to the PQR. With this Q&A session, you will clear so many key requirements about PQRSection 3 – Pharmaceutical Quality System (PQS) - This section will primarily focus on pharmaceutical quality system requirements as per ICH Q10, ISO, and, EUGMP guidelines. The content of this section is as below.• Understanding the different guidelines• ICH Q10 Objectives• Life Cycle Approach• Management Responsibility• Elements of Pharmaceutical Quality System• Key messageIn this same section of PQS, there is one more lecture for key questions and answers related to the PQS. With this Q&A session, you will clear so many key requirements about PQSSection 4-Change Management System (Change Control) – This section focuses on the change management system followed in the pharmaceutical industries. The content of this section is as below.• Need for Change Control• Guideline expectations about change controls EU, FDA, ICH, PIC/S, ISO, etc.• PDCA Cycle in relation to Change controls• Change Control Life cycle approach• Types of change controls – Categorization using Heat Matrix• Artificial Intelligence - Scope in Change Control• cGXP Computerized systems – Scope in Change Control• Normally missing in Change Controls learn from FDA citationsSection 5 -Deviation management - This section focused on the deviation management system followed in the pharmaceutical industries. The content of this section is as below.• Guideline expectations about deviations- EU, FDA, ICH, ANVISA, ISO, etc.• Detailed understanding of deviations• Scientific way for categorization of deviations -Simplified risk assessment tool in line with WHO recommendations• Categorization strategy for repeat deviations• Effective writing of deviations• Trending – Points need to considerSection 6- Out-of-specification (OOS) and Out-of-trend (OOT) management - This section focused on the out-of-specification and out-of-trend management followed in the pharmaceutical industries. The content of this section is as below.• Regulatory requirements• FDA Citations• Learning about OOS• Resampling and Retesting• Outlier Tests• Understanding of OOTSection 7-Corrective and preventive actions (CAPA) - This section focused on the Corrective and preventive actions in line with the Poka Yoke Principle. The content of this section is as below.• Guideline Requirements• Some FDA Citations• Understanding of the CAPA terminology• Corrective Vs Preventive Actions• Understanding Poka-Yoke Concept• The Poka-Yoke 2-step working process• Process of mistake-proof actions• Benefits of Poka –Yoke• Examples- General as well as pharmaceutical
Who this course is for:
Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, IT, R&D, development, investigation team, compliance team etc.
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