Good Manufacturing Practices For Pharmaceuticals

Include Good practices in warehouse, analytical and, microbiology laboratory, data integrity and computerised system.

What you'll learn

Pharmacy,pharmaceuticals professionals

This course has been updated to include the advances in Current Good Manufacturing Practices. This is two-days course

This is very important training. Failure to learn GMP principles can loose product and production licences.

Everyone who is working in pharmaceutical should be trained on this course

Requirements

The person who is interested in learning should learn in focussed way to understand the concepts and practical approach.

Description

This course will help learners to understand good manufacturing practices. This course is prepared with special attention on good warehouse practices, good laboratory practices, good computerized systems, and good data integrity practices. Further, this course will discuss good documentation practices and good review practices also. Further emphasis will be Good behaviour practices are also considered while developing this course. As, Good behaviour will first be required to ensure data integrity and good manufacturing practices. This course will further specifically have lectures on data integrity aspects of analytical laboratories and microbiology laboratories.This course is having many lectures. Below different points will be discussed in the lecturesInvestigations, OOS, OOT in pharmaceuticals, stability study in pharmaceuticals, guideline expectations about different aspects of GMP, FDA citations, the computerized system compliance includes -  FDA part 11, business continuity plan, and excel spreadsheet validation also.How you can be ready for inspection is also discussed with a special focus on computerized system requirements. Overall, this is the complete course for learning pharmaceuticals in all disciplines. This course contains many recorded lectures. Kindly request you fully focus on each lecture to understand it in a better way.Further, if you have any question/s, please put your questions in the comment section. I will respond to your questions.

Overview

Section 1: Good Warehouse Practices

Lecture 1 Introduction

Lecture 2 GMP in warehouse Part 1

Lecture 3 GMP in warehouser part II

Section 2: Good Laboratory Practices

Lecture 4 Good Behaviour Practices

Lecture 5 Stability Study

Lecture 6 OOS and OOT investigations

Lecture 7 Analytical method validation

Section 3: Data Integrity in Pharmaceuticals

Lecture 8 Data Integrity and audit trail review part 2

Lecture 9 Data Integrity in analytial laboratories

Lecture 10 Data Integrity in Microbiology Laboratories

Section 4: Good Documentation Practices

Lecture 11 Good Documentation Practices Vs data integrity

Lecture 12 Good Review Practices

Section 5: Good Computerised System/IT practices

Lecture 13 Excel Spreadsheet Validation

Lecture 14 Common Errors related to cGXP computerised system

Lecture 15 FDA part 11 compliance

Lecture 16 Business Continuity Plan

Pharmacy students, consultants, This course is essential for software vendors, auditors, and quality staff involved in GxP applications. • Regulatory Affairs • QA/ QC • IT/IS • Software Managers • Project Managers • Software vendors and suppliers