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Validation Trainer

Validation is a requirement of Good Manufacturing Practices (GMP). As defined by FDA's 1987 Guideline on General Principles of Process Validation, validation - such as pharmaceutical validation - is "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product, meeting its pre-determined specifications and quality attributes".

Why this course ?

Validation plays a Key Role in Pharmaceutial , Clinical Trial , Medical Device , Food, Biological industries. Validation helps one establish and demonstrate that a particular activity is maintaining a desired level of compliance. Understand Regulatory Concepts, Able to write and review Regulatory Documents Marketing Authorization from different countries, Become an RA professional Preparation for audits and inspections.

Course Features

  • Instructor Live Sessions

    There will be allocated hours of instructor with Live classroom and Simultaneously on Online.
  • Real Time Studies

    Live project based on any of the selected use cases on the above selected Domain.
  • Assignments

    Each class will be followed by practical assignments which can be completed before the next class. 
  • Lifetime Access

    You can get lifetime availability of class recordings and presentations can be shared with you, you can download and Stored in your system.
  • 24/7 Support

    We have 24x7 support team available to help you with any technical queries you may have during the course and after completion of the course with in a year.
  • Certification

    Towards the end of the course, you will be working on a project. Covalent certifies you as an course Expert based on the project.

Course Curriculum

Download
  • Validation Trainer

    • Introduction to Pharma industry.
    • What is Regulatory Affairs? And its role.
    • Importance of RA department, Roles and their functions, worldwide regulatory agencies and their roles.
    • Notes on clinical trials, Drug development, Pre-formulation studies, API characterization, Generics and Innovator drugs,
    • ICH guidelines: Stability Testing of New Drug Substances and Drug Products, Photo stability Testing of New Drug Substances and Products, Stability Testing for New Dosage Forms, Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products, Evaluation of Stability Data, Impurities in New Drug Substances, Impurities in New Drug Products, Impurities: Guideline for Residual Solvents, good manufacturing practise and Pharmaceutical Development,.
    • Discussion in details on Common Technical Document CTD (Module 1 to 5)
    • USFDA Introduction, ANDA Regulatory Approval Process (US), Hatch-Waxman act, Patents and their types,Post approval changes (Annual reports, CB-30 and prior approval supplements), Types of DMF’s, Rules and guidelines.
    • Drug regulatory authorities in European Union (EU), different types of approval procedures (MRP, DCP, National and Centralized Procedures), brief study on post approval changes (variations and extensions), approval procedures for drug substance (DMF and CEP), rules and regulations
    • Quality Assurance (QA) general concepts and SOP preparation & maintenance.
    • Introduction to validations and their types (concurrent, prospective, retrospective and revalidation).
    • Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Procedures and Validation master plan (VMP)
    • Validation of Analytical Methods and process validation
    • Sterilization basics, selection of sterilization method and its overview

Projects

  • Project on Regulatory Affairs & Validation

    Realtime project on Regulatory Affairs & Validation

FAQ's

  • Can I attend a demo session before enrollment?

    Yes

  • What if I miss a class ?

    If you miss a class we can provide recording video for particular session or we can arrange you the back up session. 

  • Will I get placement Assistance ?

    Yes

  • Do I receive a certificate for training ?

    Yes

  • What support is available after the training?

    Doubts clarification up to getting a job

    Resume preparation

    Malk interviews

    Placement Assistance

  • What Features do you provide?

    Class Room & Online Live sessions
    Real time projects
    Working faculties
    Lab facilities
    Placement assistance
    Resume preparation
    Software installation
    Doughts Clarification & Job Support.

Certifications

  • Certificate/Certification

    Covalent provides training certificate after completion of the course. 

Videos

Validation Trainer Demo

Reviews

Naveen Kumar Reddy K

QC Executive

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