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 PQR

In 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 PQR

Section 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 message

In 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 PQS

Section 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 citations

Section 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 consider

Section 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 OOT

Section 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