What you'll learn
Upcon completion of the course,participants will learn and equipped to Undertand the cGMP requirements in line with regulatory guidelines
The cGMP training is mandatory for all pharma professionals
All the personnel working in the area should be trained on current good manufacturing practices on continual basis
This training will help to develop current quality sight towards compliance
Requirements
The person should be full focussed during the session.
Description
As per FDA guide, (a) Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions.Training shall be in the particular operations that the employee performs and in current good manufacturing practice.As per EU guide, The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product.Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them.This training program is uniquely designed to comply the different regulatory expectations.This program comprise of total 13 lectures. Which touches all the parts of GMPs like - Training requirements, Quality Risk management, inspection readyness for cGXP computerised systems, 21 CFR Part 210 and 211 with eCFR concept, Building quality culture with 21 steps appraoch and further how to establish the quality culture in the organisation, Good behavioural aspect of GMP training, Pharmaceutical quality system is very important when we discuss about the GMP training.Further there are other topics with recorded sessions which includes - Quality management maturity (QMM) program by FDA, Most of the personnel prepares the trend but could not evaluate correctly. So, one topic is on evaluation of the trends.After that there is separate topcis with recorded sessions on deviation, change control and CAPA.This training session will cover complete cGMP requirements in about 12 hours of the lectures. Further more, if you have any question/s or need any clarification/s, please put your questions in comment section. I will respond you.
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 Quality Risk Management
Lecture 3 Inspection Readiness For Computerised Systems
Lecture 4 21 CFR Part 210, 211 and eCFR
Lecture 5 Building The Quality Culture With 21 Step Approach
Lecture 6 Establishing Quality Culture
Lecture 7 Good Behaviour Practices - GMP Training
Lecture 8 Pharmaceutical Quality System (PQS)
Lecture 9 Quality Management Maturity (QMM) Program by FDA
Lecture 10 How to Evaluate Trend
Lecture 11 Deviations - A Practical and Compliance View
Lecture 12 Change Control - A Practical and Compliance View
Lecture 13 Corrective and Preventive Actions Based on Poka-Yoke Principle
Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.
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