Brief on PLC Validation and Compliance

Focused View

Hitendrakumar Shah

4:57:30

29 View

1. Common Errrors Related to GXP Computerised System in Pharmaceutical.mp4

08:06

2. Brief on HMI,PLC and SCADA.mp4

01:00:12

3. Brief on Computerised System Validation.mp4

01:41:53

4. Brief on PLC Validation Session - I.mp4

01:01:15

5. A Brief on PLC Validation Session - II.mp4

01:06:04

Description

A brief understanding and compliance to PLC Validation for Pharmaceuticals

What You'll Learn?

You will understand brief about HMI. PLC and SCADA. Different validation strategies.
How Agile approach and water fall approach is used
Developing the validation skills,You will able to understand PLC validation strategies.
What is QTP testing and manual testing

Who is this for?

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

The persons involved in review and approval of cGXP computerised system and its validation, PLC validation and controls etc.

What You Need to Know?

The person should be full focussed during the session.

More details

Description
The participants of the course will understand the common errors made related to cGXP computerized systems. The course consists of different recorded lectures.
The first lecture is designed to teach the basics about HMI, PLC, and SCADA. This lecture includes a brief understanding of HMI, Industrial Usage of HMI, Benefits of HMI, a Brief understanding of PLC, Major considerations of URS in PLC, a Discussion on drawbacks of PLC, a Brief understanding of SCADA and Components of SCADA.
A Separate lecture on the basics of computerized system validation. This lecture briefly includes the importance of the topic, Introduction to Pharma 4.0, Purpose and Scope, GAMP5, Categories of Hardware and software, Validation strategies, Understanding URS, FRS, FAT, SAT, IQ, OQ, PQ, UAT, Validation plan Vs Validation Master Plan- VR Vs VMR and Major changes in GAMP 5.
The lecture on PLC validation part (Session)-1 is designed to include a brief introduction of the concept, PLC, validation strategy, Types of GXP computerized systems, Requirements for Validation, Understanding Traceability Matrix, Elements of Functional Risk Assessment (FRA), Infrastructure Risk Assessment, Process Control System validation requirements, Identifying GXP and non-GXP systems, Criticality based on system complexity and Validation of PLC logic.
The last lecture on PLC validation Part (Session)-II is designed to include a quick recap from Session â€“ 1, an Understanding of different test strategies, a Brief on white box and black box testing, Agile testing approach during PLC validation.Difference between the Agile Approach and Waterfall approach, Verification vs. validation, QTP (Quick Test Professional) and Manual testing, Stages of Manual testing, and System Retirement Plan
Who this course is for:
Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), Pharma IT, Lab Compliance, production, engineering, R&D, development, investigation team, compliance team etc.
The persons involved in review and approval of cGXP computerised system and its validation, PLC validation and controls etc.

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Electronics

PLC

Hitendrakumar Shah

Instructor's Courses

A Quality-oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality Engineering, Quality auditor, pharmaceutical regulations, and regulatory audit compliance.The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.The key competencies include Quality Compliance, Supplier Audit, building systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation, and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post-approval queries raised by regulatory agencies, etc. ·Independently handled - Quality assurance and Quality Control department for more than 13 years.· Audits faced- USFDA (7 times), ANVISA, MHRA, MCC, TGA, IDMA excellence, WHO audit, EU regulatory (8 times), Yemen MOH, Digemid (Peru), Russian Authority audit, etc.· Analytical Background: The analytical background includes, physical, chemical, and microbiological testing of raw material, finished product, and stability samples. Handled the chromatographic instruments – HPLC, GC, IR, UV-visible spectrophotometer, AAS, etc.· Technical support-o cGMP and data integrity gap audit.o Support in facing regulatory audits & compliance report reviewo Support in product development and/or regulatory submission or evaluation of readymade dossiers which can be used after site transfer for commercial manufacturing.· Expertise in GXP Computerised systems-o Major Software handled - Lab solution software, Empower 3 software, LIMS, TRIMS & Track wiseo Provide technical support to process owner during Computer system validation, Review of Computerised system validation documents for compliance, auditing the computer system supplier, performing GAP audit of Computerised systems, Evaluation of Computerised systems with respect to cGXP compliance, data integrity controls and ease of operating pragmatic approach· During tenure audited more than 500 vendors/suppliers and trained more than 5000 candidates. I am an approved Auditor by the multinationals I worked and also I am a CQI-IRCA Certified QMS/Lead Auditor as per ISO9001:2015).

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