Current Good Manufacturing Practices (cGMP) in Pharma

Name: Current Good Manufacturing Practices (cGMP) in Pharma
Rating: 4.2 (141 reviews)

cGMP in Pharmaceuticals

Created byHitendrakumar Shah

Last updated 10/2024

English

English [Auto],

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

Course content

1 section • 13 lectures • 12h 12m total length

Introduction9:38
Develop a compliant cGMP training strategy by outlining induction, on-the-job, and SOP training, emphasizing health and hygiene, cross-contamination control, and data integrity, with solid documentation.
Quality Risk Management8:48
Learn quality risk management in pharma through proactive identification, risk assessment, and prioritization using RPN and FMEA, with practical cGMP process examples and mitigation planning.
Inspection Readiness For Computerised Systems8:16
Prepare for inspections by compiling the complete list and inventory of GXP computerized systems, validating them with a risk-based plan, and enforcing change control, training, data protection, and periodic reviews.
21 CFR Part 210, 211 and eCFR1:02:35
Interpret 21 CFR parts 210 and 211 and the eCFR, and apply cGMPs in pharma through case studies on training, doer and checker, gowning, and lighting and washing facilities.
Building The Quality Culture With 21 Step Approach1:20:35
Build a strong quality culture in pharma with a 21-step approach aligned to cGMP, EU GMP, US FDA, and PIC/S guidelines, emphasizing management accountability and open data integrity.
Establishing Quality Culture1:01:34
Establish a proactive quality culture in pharma by integrating management leadership, transparent deviation reporting, and continual improvement through variability investigations, risk management, and preventive actions.
Good Behaviour Practices - GMP Training56:23
Explore good behavior practices as the core of cGMP, highlighting how right attitude, proper gowning, accurate data handling, and proactive reporting prevent quality issues and data integrity breaches.
Pharmaceutical Quality System (PQS)1:13:50
Explore the pharmaceutical quality system within current good manufacturing practices, detailing lifecycle elements, management responsibilities, and continual improvement through change control, corrective and preventive actions, and risk management.
Quality Management Maturity (QMM) Program by FDA55:15
How to Evaluate Trend1:07:39
Explore how to evaluate trends in GMP data to detect out-of-trend results, variability, and process drift. Apply training, trend-based CAPA, and regulatory guidelines (FDA Q7, Eudralex) for ongoing quality improvement.
Deviations - A Practical and Compliance View1:23:39
Explore deviations in pharma under cGMP, using a risk-based categorization, investigations, root-cause analysis, and CAPA within a quality management system.
Change Control - A Practical and Compliance View1:26:40
Adopt a pragmatic, compliance-driven change control approach within cgmp. Master life-cycle management, risk assessment, pdca cycles, and regulatory expectations from fda, ich, and who.
Corrective and Preventive Actions Based on Poka-Yoke Principle1:17:44
Explore corrective and preventive actions based on the poka-yoke principle in pharma cGMP, focusing on root-cause analysis, two-stage mistake-proofing, and practical examples.

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.

Who this course is for:

Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.