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Best Online Institute for CSV & LIMS - Company Connect Consultancy

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LIMS End to End Project Learning 

Laboratory Information Management Systems (LIMS) are widely used in the laboratories of pharmaceuticals and related industries. LIMS is typically based on client server technology supported by a Relational Database Management System (RDBMS) as a storage repository. 

LIMS is now a mature technology, and many packages are commercially available. Therefore, this chapter will concentrate on the selection, configuration, and implementation of a LIMS in a pharmaceutical manufacturing environment, rather than the development of in-house software for laboratory management.

The introduction of LIMS into the laboratory is encouraged by Quality Assurance (QA)/Quality Control (QC) laboratory managers. It provides an automated, efficient, and regulatory-compliant means of dealing with the electronic data produced in the laboratory. The implementation of LIMS should also reduce the possibility of errors due to problems introduced by personnel performing repetitive scheduled tasks. There have been increasing demands from the regulatory authorities for data integrity, data security, and validation of LIMS in line with the current regulations and guidelines, 1–4 with LIMS becoming a focus of interest for these pharmaceutical regulators.

In this training Course you will learn End to End LIMS system Implementation from requirement gathering, Validation approach, Validation Plan preparation, functional and design understanding including architecture design aspects, Test scripting and its execution and finally preparation of Validation Summary Report. 

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 Module 1: LIMS Functionality and Technology

  • Module 1: Flow Chart-LIMS, URS, how to create LIMS Master Data –Analysis, Product, Sample plan & Item code

  • Module 2: Defining Business Requirements For LIMS (User Requirements Specification) –Initiation phase

  • Validation Life-Cycle Approach through GxP Computerized systems-Initiation phase

  • Module 3: LIMS GXP Assessment, Validation plan-FRA, FCS, IQ, OQ and PQ, how to create LIMS Master Data –Inventory

  • Module 4: Configuration testing in Dev.- environment, Functional Testing in Quality environment, UAT Testing in Prod-environment, Basic awareness of Crystal reports

  • Module 5: How to prepare the LIMS Validation summary Report, Environmental monitoring Module Workflow.

  • Module 6: LIMS Architecture, Creation of Master data inventory and Inventory management workflow

  • Module 7: Lot Management Workflow, Laboratory workflow and Master data instrument creation and Instrument Management workflow

  •  Module 8: Stability Management-Introduction, Stability storage Location management and Stability management entire workflow

  • Module 9: LIMS Administration activities: User Management, Data Migration, Object package creation, installation and scheduler management in LIMS ,Investigation Management-LIMS.

  • System Overview Description with diagrams (a concise nontechnical description of thfunctionality and operation of the LIMS covering all interconnected systems), which for complex systems should be a separate document providing a description of the systems that may be used to describe the system to a regulator

  1. System Architecture with details of hardware with diagrams

  2. Data Architecture with details of the sources, uses, and ownership of each static data item

  3. System landscape showing the interactions of the various instances of the application

  4. Interfaces with diagrams (including networks, systems, and analytical equipment)

  5. List of software modules with details of versions, standard software products (e.g. spreadsheet packages), etc.

  6. Number of users, user hierarchy, and response time required from LIMS

  7. Software design documentation

  8. Server environmental conditions including power supplies

  9. Client PC user interface software configuration details and terminal emulation requirements

  10. Functional descriptions of LIMS operations

  11. Business Continuity (Contingency) Plans, maintenance, and operating procedures

  12. Application software and reports

  13. Security and access control methods

Eligibility

Graduation/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Executive Diploma, Industry Certificate, and Certificate Programmes.

Programme Duration

The candidate is expected to complete the course in 1 months weekend classes

Registration

The registration will be carried out by contacting on Company Connect Consultancy. How to Apply

Programme Deliverables

A comprehensive study material for all the modules in Soft copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

  • Assignments for all the programme modules for continuous evaluation and guidance.

  • Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.

  • Online classes for all the modules will be conducted on the weekdays or Weekend (as per batch you choose). Moreover, a doubt clearing session will also be scheduled before the examination.

  • All the efforts are made by faculty members to make the entire programme modules easily understandable.

  • Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.

  • At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.

  • All learning and training delivery initiatives shall be conducted in English.

Certification and Membership Fees

Contact on +91-9691633901 or Info@companysconnects.com for details of fees structure 

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. 

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like IQVIA, Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc.