GAMP 5 & 21 CFR Part 11 Compliance With Computer System Validation

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1 Course Objectives: GAMP 5 & Computer System Validation issues are like Diabetes it is not hard to controlled by better life style. If not controlled it can be source of many diseases when combined with other disease attack. Now as full GMP slowly coming to computers Data Integrity issue has become like Diabetes. If not controlled it can harm ever where and it can be dangerous. Only way to control is to live controlled and better compliance life style and medication (Training in case of data Integrity from good trainer). Marcep Inc. along with Mr. Kalpesh Vaghela s extensive years of experience in the field of third party audit of Data Integrity issues announcing the workshop for Indian Pharm Industry. Which can help Indian Pharma Sector to better understand & can help reduce 483 and warning letter by great amount. When we see lot of company getting 483 and warning letters. Which is very sad for backbone for our nation s growth. After doing extensive research from our regular pharma client s & industry insight we are happy to offer you the training for your esteem pharma executive to reduce the risk of GAMP 5 & 21 CF part 11 Compliance with CSV. Using the GAMP Good Practice Guide: A isk Based Approach to Compliant Electronic ecords and Signatures as a resource, this course will give participants a practical introduction to the 21 CF Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-theminute information on the status of FDA's current re- examination of the regulation, including a discussion of the agency's latest Part 11- related guidance and inspection assignments. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues. A central element of this course will be an explanation of the GAMP approach to 21 CF Part 11 compliance, as well as compliance with other international regulations covering electronic records and signatures. The GAMP Guide provides timely and much needed direction on meeting current regulatory expectations for compliant electronic records and signatures. The Guide describes how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, through the application of appropriate controls commensurate wie impact of records and the risks to those records.

2 Day One Two day training modules: Day Two Why Validation? Why the need for Validation came in to picture. History Of Validation Benefits of Validation V Module How we can get Good System Validation Definition GAMP4 V/S GAMP5 Types of Validation Prospective, Concurrent and etrospective. Validation Documentation Validation Plan and Validation eport Supplier Agreement Vendor Assessment eport GAMP5 Basics GAMP5 Drivers Software and Hardware category as per GAMP5 21 CF Part 11 Compliance in Details, Data Integrity and Security. Basic and Advance Two Session Main points Legacy System Open System Close System Electronic ecords Hybrid Systems Electronic Signature Digital Signatures Black box White box Data backup estoration, Archival- etrival and data etention. Annex 11 Data Integrity and Security ALCOA Maintenance Qualification Concepts of CSV Advantages of Validation If time permits How validation helps to improve your business Computer Validation as per GAMP5 Why Validation? Deliverables of the Validation VMP, US, FS, DS, IA, FA, IQ, OQ, PQ, TM, S. Using risk based approach for CSV Benefit of isk Assessment Steps for CSV if time permits Formation of Validation Team Why to Write meaningful specifications/requirements (US) Deliverable SS, GXP Assessment, isk Assessment, IQ, OQ, Traceability Matrix, Summary eport isk Assessment Sod, PN no. Selecting and qualifying the right vendor isk Based Approach as per GAMP category Installing and testing the system for correct operation Validation of existing system evalidation Vendor Qualification, SLA Difference between Qualification and Validation isk Assessment Basic Understanding Various types of isk Assessment method Example Benefit of risk assessment in large project Missed Our Training On: Data Integrity & Ensuring GMP Six Systems Compliance Don t worry all participants will get the training material free through our corporate loyalty program.

3 Course Director: Kalpesh Vaghela, Software Validation Specialist. Expert Trainer on Electronic EBM and EBP, GAMP5, 21 CF Part 11 Compliance, ICH Q9 isk Assessment. Since last two decades Mr. Vaghela is helping Indian and International Pharma Companies achieve Compliance, Train and Motivates Staff for ight First Time Approach. Quality by Design, built inside the subconscious of the production and Quality team. With extensive years of work experience with India s Major Pharma Companies & a decade of dedicated experience in software validation. Validation/ isk Assessment jobs carried out in USA, Europe, China, Middle East and Africa. egarded as authority in the fields of Validation and Calibration. Supported many USFDA, MHA, ANVISA, MCC, TGA Customer Audits as a consultant. With 10 year of work experience on high level CSV Validation in India and Abroad has made Mr. Vaghela an expert in special Data integrity Audit for Pharma. Training program plus review, Change and Capa procedures. People are gaining a lot. Cost of non compliance is extremely high. he has tie up with world renowned team like Premier Validation UK, FDASmart, Life Science Expertise- France, Atachi USA (MES), Learn About GMP Online Platform from USA and many more. Select Client List include: Mylan, Piramal Health Care, Sun Pharma, Alembic, Wockhardt, Dr eddy's Lab, anbaxy, Glenmark Fresenius Kabi, Abbott, Watson Mumbai- Ice land And many more International client list Includes Giants: Emerson process Management- China BMS/ EMS and Training, Horiba- Yuovn Scientific- Japan, France aman Spectroscopy Lab Instrument, Muscat Pharmacy- Biggest etail chain of Middle East for Pharma- foodmedical devices. Morton Grooves- Chicago Il USA, Watson Iceland, Premier Validation U.K. etc. Marcep Inc. is training and consulting provider for pharma sector In India. MACEP INC. train s executive s of all sectors and we do actual work so our motive behind training is to help the skills sharpening for the pharma workforce. Marcep Inc. expert team of CSV can help you in: 1) Computer Systems Validation for Manufacturing Area 2) Computer Systems Validation for Laboratory Area and Instruments 3) CSV Validation for all types of EP SAP Systems 4) CSV Validation for BMS Systems 5) CSV for Document management Learning management Systems 6) CSV for EBM and EBP as well as MES Systems 7) CSV for Excel Validation 8) CSV for Clinical esearch Software 9) Audit and GAP Analysis for 21 CF Part 11 Compliance and Annex 11 Compliance 10) Fool proof System owner job validation like Data Integrity, Backup restoration, Archival- retrieval data etention and Migration check. 11) Compliance Training on Why Validation?, ole of FDA, 21 CF part 11 Compliance, Annex- 11, GAMP5, isk Assessment, CSV Deliverables, Data Integrity. We have successfully worked in USA, Europe, Ireland, Ice Land, China, South Africa, Middle East and now gearing up to serve the whole world in a big way. Best quality services at reasonable price and true positive surprise to client by good quality, accurate and timely work is our motto. If you are looking for the good partner who can help you in producing quality product, it is a time to contact us. You can trust us for USFDA, MHA, TGA, ANVISA, MCC and other critical Audit. Good CSV can help you educe CAPA, Change Control, Batch ecall and give all people on earth a good Peace of mind including your shareholders. Data Integrity, Security, Patient safety and Product Quality is a key thing. We are regarded as No.1 software validation company of India with presence in India and abroad. Good Care needed to be taken while selecting the Software Validation Consultant in checking their Facility, Company Management, Management Goals, anking Industry wise and Pharma Sector Wise.

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