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PHARMACOVIGILANCE

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.

  • Introduction to Pharmacovigilance (PV) Course curriculum.
  •  PV Career scope & PV Companies in India.
  •  Introduction to Pharmacovigilance (PV) Basics.
  •  PV Terminologies & Glossary.
  •  PV Websites.
  •  MedDRA Coding.
  • ICH Guidelines (E2A to E2F).
  •  GVP Modules (1 to 16 Modules).
  •  Causality Assessment.
  •  Safety Narrative Writing (3 Types of Narratives, Spontaneous, Clinical Trial & Literature).
  •  Training on PV Database, PV Work Flows & Different software’s in PV Industry.
  •  Vaccine Pharmacovigilance.
  •  Materiovigilance (Medical Device).

3 Types :
Weekend Batch : 3 Months
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

15000 RS for Indian Students.

20000 RS for NRI Students.

1. What is the Qualification For Pursuing the course:
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Pharmacovigilance Job : From 13000 RS per month to 23000 RS/26000 RS depending
on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing
the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success.
We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the
second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Pharmacovigilance : Progressive & Prosperous.
10. Is there any abroad Opportunities For Pharmacovigilance : Yes, with good experience this chance of
abroad opportunities through the companies or through the experience you gained and doing masters would enable
more chances of getting good Pharmacovigilance jobs.

ARGUS SAFETY FOR ADMINISTRATORS

Argus Safety assists manufacturers of pharmaceuticals and devices by providing a simple and efficient way to comply with international and domestic regulatory safety reporting requirements.

Module – 1: Argus Safety Configuration

Codelist configuration :

Argus Console overview.

Codelist configuration.

Flexible Data Re-categorization configuration.

Business configuration :

Business configuration overview.

Company products configuration.

Regulatory reporting rules configuration.

Studies configuration.

Access management :

Access management overview.

Users configuration.

Sites configuration.

Group configuration.

System configuration :

System Configuration overview.

Case priority setup.

Field validations configuration.

Field properties.

Argus system case numbering setup.

System Management.

Workflow configuration.

SMTP configuration and it’s uses.

Module – 2: Argus Safety Technical Aspects:

Argus Safety Architectural Overview and Details :

Argus Safety Web Server.

Argus Safety Services.

Argus Interchange overview.

Axway (E2B) Gateway overview.

Argus Safety Troubleshooting Tips :

AG Service Configuration and Logs.

ESM Service Configuration and Logs.

SQL TIMES.

Error Log.

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

30,000 RS for Indian Students.

35,000 RS for NRI Students.

PHARMACOVIGILANCE COURSE-ADVANCED

Pharmacovigilance is of the interesting and Challenging fields a Life science graduate can pursue is Pharmacovigilance. Pharmacovigilance or Drug safety is one of the most critical steps involved in the drug development and Clinical trial process. It mainly involves the collection, analysis, monitoring, and prevention of adverse effects in drugs and therapies. It is present to make sure the patient’s wellbeing is taken care of throughout the Drug Development Cycle.

PADERs : 
1. PADER calendar  preparation.
2. Timelines and submission procedures
3. Drafting of pader  as per the temple.
4. Line listing generation.
 
PSURs/PBRERs:
1. Calendar preparation
2. Stakeholder communication procedures
3. Timelines and submission procedures
4. Drafting of PSUR and PBRER
5. Line listing generation
 
Risk Management plan:
1. What is  RMP and regulatory requirements
2. Timeline and submission procedures
3. Drafting of RMP as per the EU guidelines.
4.  Revision of RMPs
 
Signal Management:
1. What is  signal and regulatory requirements.
2. Signal calendar preparation
3. Line listing review
4. Signal detection process
5. Drafting signal detection reports as per EU requirements.

3 Types :
Weekend Batch : 3 Months
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

20,000 RS for Indian Students.

25,000 RS for NRI Students.

1. What is the Qualification For Doing this course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Pharmacovigilance Job : From 15000 RS per month to 25000 RS/30000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Pharmacovigilance : Progressive & Prosperous.
10. Is there any abroad Opportunities For Pharmacovigilance : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Pharmacovigilance jobs.

DRUG SAFETY PHYSICIAN COURSE PHARMACOVIGILANCE

Drug safety Physician and pharmacovigilance in areas of development and marketing of medication is an extremely important element. The importance of drug safety monitoring and risk management for medicinal product developers and clinical investigators is required to protect public health, manage increasingly tight regulations and ensure the efficient functioning of drug safety or pharmacovigilance systems within pharmaceutical and biotechnology companies.

1. Medical review of ICSRs-
  •  Medical review comments
  •  Relatedness assessment
  •  Listednes
  •  MedDRA coding
  •  Seriousness assessment IME and DME list
2. Special scenarios cases codings and assessment
3. Line listings review
4. Literature articles review and assessment
5. Medical inquires response
6. Dechallenge and dechallenge assessment.
7. Medical review of PADERs and literature assessment.
8. Medical review of PSURs/ PBRERsand literature review and assessment.
9. Medical review of signal management and literature review and assessment
10. Medical review of risk management and minimisation.

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

30,000 RS for Indian Students

35,000 RS for NRI Students

1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Drug Safety Physician Job : From33,000 RS per month to 37,000 RS/40,000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Drug Safety Physician : Progressive & Prosperous.
10. Is there any abroad Opportunities For Drug Safety Physician : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Drug Safety Physician jobs.

ARGUS SAFETY DATABASE ESSENTIALS

Argus Safety Essentials covers the basic and advanced concepts of managing drug safety data using the Oracle Argus Safety application. The course starts with an overview of Oracle Argus Safety 8.1.

Pre-req :

Prior knowledge of SQL/PL-SQL

Module -1: Pharmacovigilance

Pharmacovigilance overview
Argus Safety Overview

Module –2: Argus Safety database overview

Argus Safety database structure
Code list tables
Configuration tables
Case Data tables

Expedited Reporting Tables
Periodic Reporting Tables

Module –3: Case Study and Hands On Exercise

Case Study
Hands On Exercise

Assessment
Course Completion Certificate

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

35,000 RS for Indian Students.

40,000 RS for NRI Students.

1. What is the Qualification For Doing the course: B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Argus Safety : From 55000 RS per month to 65000 RS/70000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Argus Safety : Progressive & Prosperous.
10. Is there any abroad Opportunities For Argus Safety : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Argus Safety Jobs.

PHARMACOVIGILANCE SYSTEM MASTER FILE

The pharmacovigilance system master file (PSMF) is a detailed description of the pharmacovigilance system used by the MAH with respect to one or more authorised medicinal products.

Objectives

  • Registration and maintenance
  • Summary of the applicant’s pharmacovigilance system
  • Location, registration and maintenance
  • Transfers of responsibilities for the pharmacovigilance system master file
  • The representation of pharmacovigilance systems
  • Information to be contained in the pharmacovigilance system master file
  • PSMF section on qualified person responsible for pharmacovigilance (QPPV)
  • PSMF section on the organisational structure of the marketing authorisation holder
  • PSMF section on the sources of safety data
  • PSMF section on computerised systems and databases
  • PSMF section on pharmacovigilance processes
  • PSMF section on pharmacovigilance system performance
  • PSMF section on quality system
  • Annex to the PSMF
  • Change control, logbook, versions and archiving
  • Pharmacovigilance system master file presentation

Course Duration :           8 to 10 Hours

✔ Batches                 :           Weekdays and Weekend Batch

✔ Weekdays             :           Monday to Friday

✔  Weekends            :           Saturday & Sunday

20,000 RS for Indian Students.

25,000 RS for NRI Students.

1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Pharmacovigilance System Master File: From 25000 RS per month to 30000 RS/35000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Pharmacovigilance System Master File : Progressive & Prosperous.
10. Is there any abroad Opportunities For Pharmacovigilance System Master File: Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Pharmacovigilance Jobs.

BASIC TRAINING ON ARGUS OR ANY APPLICATION SETUP

Oracle Argus Training teaches you how to implement, configure, navigate and use Oracle Argus products.

Computer System Validation (CSV)  requirement

  •  User requirement specification
  • Vendor assessment
  • Change control initiation
  • Initial risk assessment
  • Validation Plan Design Specification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Validation summary report
  • Traceability Matrix
  • Impact assessment

Course Duration  :           8 to 10 Hours

Batches                 :           Weekdays and Weekend Batch

Weekdays             :           Monday to Friday

Weekends            :           Saturday & Sunday

20,000 RS for Indian Students.

25,000 RS for NRI Students.

1. What is the Qualification For Doing the course: B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Oracle Argus Database: From 20000 RS per month to 22000 RS/23000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Oracle Argus Database : Progressive & Prosperous.
10. Is there any abroad Opportunities For Oracle Argus Database : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Pharmacovigilance Jobs.

MEDICAL WRITING

Medical writing is a profession dedicated to the communication of medical, scientific, and health information,
including research reports, patient information, and regulatory documents.

  • Introduction to Medical Writing.
  • Clinical Trial Terminologies and Definitions.

Clinical:

  • Clinical Trial Protocol.
  • Clinical Study Reports.
  • Informed Consent Form, Case Record Form.

Regulatory/Labelling:

  • Preparation of PIL/PI/SmPC.
  • Clinical and Nonclinical Overviews and Summaries.
  • Justification document, Addendum, Bio-waiver Justification.
  • Core Data Sheet/ Core Safety Information.

Publication:

  • Journal/Abstract.
  • White Paper Presentation.

Medico-Marketing:

  • Continuous Medical Education, Physician Desk Reference.

Total 20 hrs. (+ 5 hrs. post-training queries support over TC)

20,000 RS for Indian Students.

25,000 RS for NRI Students.

1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Medical Writing Job : From 20000 RS per month to 25000 RS/30000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Medical Writing : Progressive & Prosperous.
10. Is there any abroad Opportunities For Medical Writing : Yes, with good experience this chance of abroad opportunities through the companies or through
the experience you gained and doing masters would enable more chances of getting good Medical Writing jobs.

CLINICAL DATA MANAGEMENT

Clinical data management (CDM) is a critical process in clinical research, which leads to the generation of high-quality,
reliable, and statistically sound data from clinical trials.

Module – 1:

Introduction to Clinical Research and Clinical Data Management

Roles & Responsibilities of Key Stakeholders.

Standard Operating Procedures.

Study Set-up Phase :

Module – 2:

Creation of Study set-up documents

Protocol Orientation.

Preparation of DMP/DHP.

CRF Design.

Preparation of DVP.

CRF Annotation.

DB-Design and Set-up.

User acceptance test.

Third party data specifications and testing.

Coding Specifications and testing.

SAE Reconciliation specifications.

Self Evident Correction specifications.

Custom reports specifications.

Study Conduct phase :

Module – 3:

Study Ongoing phaset

Tracking CRF Data.

Data Entry, Remote Data Entry.

Data review and query management.

Managing Lab Data.

Medical Coding.

SAE Reconciliation.

Post-Production Change management (PPC).

Self Evident Correction Management (SEC).

Creating Reports .

Study Close-out phase :

Module – 4:

Study Close out phase

DB listings QC as per QC plan.

Track all data as per DB Lock checklist.

Final DB QC.

Data Base Lock.

Data Base archival and study data transfer.

Module – 5:

Case Studies

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

15,000 RS for Indian Students.

20,000 RS for NRI Students.

1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Clinical data management (CDM) Job: From 13000 RS per month to 23000 RS/26000 RS depending
on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing
the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success.
We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay fee in installments : Yes, only two installments are permitted. One before joining and the second
before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Clinical data management (CDM) : Progressive & Prosperous.
10. Is there any abroad Opportunities For Clinical data management (CDM) : Yes, with good experience this chance of
abroad opportunities through the companies or through the experience you gained and doing masters would enable more
chances of getting good Clinical data management (CDM) jobs.

CLINICAL RESEARCH

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices,
diagnostic products and treatment regimens intended for human use.

  • Introduction to CR – 2 hrs

a) Definitions and types of CR.
b) Overview of CR processes.
c) Opportunities in CR.
d) Career Development in CR.

  • BA/BE studies-Clinical and Regulatory procedures-ANDA-21 CFR 320 – 4 hrs.
  • CRO-Organization, Structure, Role, Responsibilities, Costing – 4 hrs.
  • Contracts and Agreements—CDA, MSA, CTA – 2 hrs.
  • Insurance and Indemnity – 1 hr.
  • Overview of SOPs/Study Plans – 2 hrs
  • Overview of Protocol, ICF, IB, AEs – 3 hrs

Responsibilities:

  • Sponsor/Investigator/EC – 4 hrs
  • Phases of Clinical Trials – 2 hrs
  • Clinical Trial Management-ICH GCP – 4 hrs

Clinical Trial Procedures:

  • Budgeting, Medical Writing, IM, SIV, SMV, SCV – 4 hrs.
  • CT-Regulatory- Indian Forms as per CDSCO-# 44, 45, 12, 11 – 2 hrs
  • US-Forms-1571, 1572, 3454, 3455 – 2 hrs
  • CT-Regulatory Procedures-India-Schedule Y – 4 hrs
  • US-21 CFR part 50, 54, 56, 312, 314 – 4 hrs
  • EU-EMEA, Australia-TGA, UK-MHRA, Canada-HPFB, Japan – 4 hrs
  • All CR related Forms-AE, SAE, Subject ID code list, Staff Delegation log, etc – 4 hrs
  • Audits and Inspections: Overview-Quality systems and SOPs – 2 hrs

Audits and Inspections:

  • Overview-Quality systems and SOPs – 4 hrs
  • Medical Devices-PMA, similarities and differences between Medical Devices and Drugs – 2 hrs

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

15,000 RS for Indian Students.

20,000 RS for NRI Students.

1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Clinical research Job : From 13000 RS per month to 23000 RS/26000 RS depending on the company
from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the
resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support
the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second
before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Clinical research : Progressive & Prosperous.
10. Is there any abroad Opportunities For Clinical research : Yes, with good experience this chance of abroad
opportunities through the companies or through the experience you gained and doing masters would enable more chances
of getting good Clinical research jobs.

CLINICAL SAS

Statistical Analysis System, or SAS, has been the industry standard for data management and analytics of large volumes of data. It’s a very flexible platform that provides users with various means to manipulate, analyze, process, and report on data.

  • SAS/BASE
  • BASIC THEORY & RULES ETC
  • SAS WINDOWING ENVIRONMENT
  • CREATION OF LIBRARIES
  • SAS PROGRAMMING (BRIEFLY)
  • DATASTEP
  • PROC STEP
  • WAYS TO READ DATA INTO SAS
  • BACK END PROCESS OF DATASTEP
  • INSTALLATION PROCESS
  • DATAWAREHOUSING CONCEPTS
  • DATASTEP
  • DATA STATEMENT &DATASET OPTIONS
  • INFILE STATEMENT & OPTIONS
  • INPUT STATEMENT &STYLES & OPTIONS
  • DATALINES STATEMENT
  • ATTRIBUTES OF THE VARIABLES
  • LENGTH, LABEL STATEMENTS
  • INFORMATS & FORMATS
  • HOW DATES WORKS IN SAS
  • ATTRIB STATEMENT & INDIVIDUAL ATTRIBUTES
  • SUM STATEMENT
  • STOP, RETAIN STATEMENTS
  • GOTO, LINK STATEMENT
  • CONDITIONAL STATEMENTS& LOOPS
  • IF, I/THEN, IF/THEN/ELSE,IF/THEN OUTPUT, IF/THEN DELETE STATEMENTS
  • WHERE STATEMENT& OPERATORS
  • DO, DO ITERATIVE, DO UNTIL & DO WHILE STATEMENTS
  • ARRAYS
  • COMBINING DATASETS
  • CONCATENATION
  • INTEREAVING
  • MERGE
  • UPDATE
  • MODIFY
  • FUNCTIONS
  • CHARACTER
  • FUNCTIONS
  • NUMERIC FUNCTIONS
  • DATE FUNCTIONS
  • OTHERS MISSING CONCEPTS
  • REVIEW OF DATASTEP
  • EXAM & DISCUSSION
  • PROC STEP
  • UTILITY PROCEDURES
  • PROC CONTENTS
  • PROC COPY
  • PROC SETINIT
  • PROC DELETE
  • PROC APPEND
  • PROC SORT
  • PROC DATASETS
  • PROC OPTIONS
  • PROC COMPARE
  • PROC TRANSPOSE
  • PROC RANK
  • PROC FORMAT
  • PROC IMPORT
  • PROC EXPORT
  • PROC CATALOG
  • PROC CPORT
  • PROC CIMPORT
  • PROC TEMPLATE
  • REVIEW OF UTILITY PROCEDURES
  • SAS/ACCESS (Banking Concepts)
  • BASIC THEORY OF SAS/ACCESS
  • WAYS TO ACCESS DATA FROM DIFFERENT SOURCES LIKE NOTEPADS, EXCEL, CSV
  • FILES, MS-ACCESS, ORACLE, DB2, SYBASE AND TERRADATA etc…
  • SQL PASS THRU QUERY
  • LIBNAME STATEMENT
  • PROC DBLOAD
  • PROC ACCESS
  • REVIEW OF ACCESS PROCEDURES
  • REPORTING PROCEDURES
  • PROC PRINT
  • PROC REPORT
  • _NULL_ REPORT (Data step Reporting)
  • REVIEW OF REPORTING PROCEDURES
  • SAS/GRAPHS & ODS CONCEPTS
  • PROC GPLOT
  • PROC GCHART
  • ODS
  • REVIEW OF GRAPHS PROCEDURES
  • SAS/STAT
  • BASIC FUNCTIONAL CLASSES OF STATISTICS
  • STATISTICAL PROCEDURES
  • PROC MEANS
  • PROC SUMMARY
  • PROC UNIVARIATE
  • REVIEW OF STATS PROCEDURES
  • SAS/MACROS
  • INTRODUCTION TO THE MACRO FACILITY
  • PURPOSE OF THE MACRO FACILITY
  • PROGRAM FLOW
  • MACRO VARIABLES
  • INTRODUCTION TO MACRO VARIABLES
  • AUTOMATIC MACRO VARIABLES
  • MACRO VARIABLE REFERENCES
  • USER-DEFINED MACRO VARIABLES
  • DELIMITING MACRO VARIABLE NAMES
  • DELETING MACRO VARIABLES
  • MACRO FUNCTIONS
  • MACRO DEFINITIONS
  • DEFINING AND CALLING A MACRO
  • MACRO PARAMETERS
  • MACRO STORAGE
  • DATA STEP AND SQL INTERFACES
  • CREATING MACRO VARIABLES IN THE DATA STEP
  • INDIRECT REFERENCES TO MACRO VARIABLES
  • RETRIEVING MACRO VARIABLES IN THE DATA STEP
  • CREATING MACRO VARIABLES IN SQL
  • MACRO PROGRAMS
  • CONDITIONAL PROCESSING
  • PARAMETER VALIDATION
  • ITERATIVE PROCESSING
  • GLOBAL AND LOCAL SYMBOL TABLES
  • FRAMEWORK FOR DEVELOPING MACRO APPLICATIONS
  • DEBUGGING AND TROUBLESHOOTING
  • GENERATING CUSTOM MESSAGES
  • CREATING EFFICIENT MACROS
  • REVIEW OF MACROS
  • PERFORMANANCE TUNING CONCEPTS
  • TESTING/DEBUGGING TECHNIQUES
  • ERROR HANDLING
  • ADDITIONAL FEATURES BETWEEN SAS VERSIONS
  • DOMAIN SPECIFIC PROJECT
  • PRACTICE
  • SDLC (Software Development Life Cycle)
  • CODING ON REAL TIME DATA
  • INTERVIEW QUESTIONS
  • RESUME
  • PREPARATION
  • WRITTEN TESTS
  • MOCK INTERVIEWS
  • DEVELOPMENT

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

30,000 RS for Indian Students.

35,000 RS for NRI Students.

1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Clinical SAS Job : From 26000 RS per month to 33000 RS/36000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Clinical SAS : Progressive & Prosperous.
10. Is there any abroad Opportunities For Clinical SAS : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Clinical SAS jobs.

UNDERSTANDING E2B R2 REPORTS

The E2B (R2) EDI service is intended for use by regulated industries and regulators to report ICSRs relating to medicines and vaccines only. Adverse events that occur during clinical trials may also be reported using the E2B (R2) EDI service.

Module- 1: E2B Introduction

What is E2B?
E2B R2 Structure
Mapping of E2B elements with ICSR data

Module -2: E2B Profile

E2B Profile Introduction
E2B Profile Definition

Module -3: Setting Up Agency for E2B Transmission in Argus Safety

Introduction to ESM Module
E2B Profile configuration
Agency set up
Data flow of ICSR (E2B) report to Agency/Partner

Module –4 : E2B Validations

What are E2B Validations?
E2B Validation set up

Module –5: Assessment

Assessment
Course completion certification

2 Types :
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

30,000 RS for Indian Students.

35,000 RS for NRI Students.

1. What is the Qualification For Doing the course :  
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for E2B(R3) Reporting Job : From 13000 RS per month to 23000 RS/26000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In E2B(R3) Reporting : Progressive & Prosperous.
10. Is there any abroad Opportunities For E2B(R3) Reporting : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good E2B(R3) Reporting jobs.

eTMF MODULE

eTMF Model is a supported initiative of the Drug Information Association’s (DIA) Document and Records Management Community and represents a single, unified interpretation of the regulations and best practices related to Trial Master Files that would be accepted by all clinical trial stakeholders, with a view to being adaptable and adopted by any organization.

1. Introduction to Essential Documents
2. Introduction DIA eTMF reference model
3. eTMF Mangement Plan
4. eTMF tools description
5. eTMF EDL creation
6. eTMF conduct
7. eTMF review
8. eTMF reconcilliation
9. eTMF document upload
10. eTMF document completion guidelines
11. eTMF demo -Viva Vault
12. eTMF demo – general systems
13. eTMF filling guidelines
14. Assessments -1
15. Mock Interview Questions

15 hours Classroom/Online Training

30,000 RS for Indian Students.

35,000 RS for NRI Students.

1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for eTMF Module : From 15000 RS per month to 18000 RS/23000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In eTMF Module : Progressive & Prosperous.
10. Is there any abroad Opportunities For eTMF Module : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good eTMF Module Jobs.

CTD/eCTD REGULATORY AFFAIRS BASICS

CTD/eCTD Regulatory Affairs is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

1. Introduction to RA profession
Regulatory Affairs Profession, role and its importance, overview of worldwide Regulatory agencies

General Overview of the Pharmaceutical Industry, its functioning, role of various Departments
like R & D, Production, RA, QA, Project Management, Supply chain etc. Within the industry

2. ICH and CTD
Overview of ICH
Introduction and overview of CTD

3. Organization of CTD
Module 1. Administrative and Prescribing Information

(Region specific)

Module 2. Common Technical Document Summaries
Module 3: “QUALITY” – CMC section of the CTD
Module 4: Nonclinical study reports
Module 5: Clinical study reports

4. Introduction to eCTD

Need to Harmonize
Origin of CTD
CTD Modules
Introduction to eCTD
Document Granularity
Advantages of eCTD
Need of eCTD Builder Software
DTD
Index.xml File
Regional xml File
USFDA

  • Admin Information in US-regional.xml
  • File Formats supported in eCTD for USFDA
  • PDF Specification for USFDA

Folder Structure
STF (Study Tagging File)
RSN Concept
Way to submit the Final Submission
Things to be taken care while preparing eCTD submission

15 hours Classroom/Online Training

15,000 RS for Indian Students.

20,000 RS for NRI Students.

1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for CTD/eCTD Regulatory Affairs : From 25000 RS per month to 30000 RS/35000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In CTD/eCTD Regulatory Affairs : Progressive & Prosperous.
10. Is there any abroad Opportunities For CTD/eCTD Regulatory Affairs : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good CTD/eCTD Regulatory Affairs Jobs.

CTD/eCTD REGULATORY AFFAIRS ADVANCED

CTD/eCTD Regulatory Affairs is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

1. Introduction to RA profession

Regulatory Affairs Profession, role and its importance, overview of Worldwide Regulatory agencies.
General Overview of the Pharmaceutical Industry, its functioning, role of various departments like R & D, Production, RA, QA, Project Management, Supply chain, etc. within the industry
2. Overview of Drug Development Process

New Drug Approval and Development
Preclinical Investigation
Investigational New Drug Application (INDA)
Clinical Investigation
New Drug Application (NDA)
Phase IV (Post marketing Surveillance)
Importance of Pharmacovigilance,
EVMPD and XEVMPD

3. Formulation or Product development

Basic formulation development and manufacturing
Importance of preformulation studies and planning
PDR writing as per ICH Q8
4. GMP , GLP and GCP

Overview of GMP
Overview of GLP
Overview of GCP
ICH GCP Guidance’s and its importance
ICH E3, ICH E6
Importance of PIC/S
5. Regulatory System in US (FDA)

History of FDA and Related Regulatory Agencies
FDA & CDER – Organization and responsibilities
Types of Drug applications in US [IND, NDA, ANDA, 505 (b)(2)]
Investigational New Drug Application: INDA
New Drug Application: NDA
Generic Drug Submissions
ANDA submission in detail
Bioequivalence Recommendation for Specific Products
Establishment registration, drug registration and National Drug Code Directory (NDC)
Changes to an approved ANDA and annual reporting
Over-the-Counter Drug Products
Regulation of OTC Drugs
Rx-to-OTC Switch
Patents and Exclusivity
Prescription Drug Labeling, Advertising and Promotion
Labeling Regulations and Requirements
Structured Product Labeling (SPL)
6. Biologics Submissions

IND Process for Biologics
Preclinical Development Considerations for Biologics
Clinical Development Considerations for Biologics
Manufacturing of Clinical Trial Material for Biologics
BLA Format and Content
BLA Review Process
Biosimilars
Vaccines and Related Biological Products
7. Drug Substance Registration Drug Master Files (DMF)

Type I —Reserved, no longer applicable
Type II — Drug substance, drug substance intermediate and material used in their preparation, or drug product
Type III — Packaging material
Type IV — Excipients, colorant, flavor, essence or material used in their preparation
Type V — FDA accepted reference material
COS/CEP
ASF
8. Life Cycle of Drug Product

Prior Approval Supplement (PAS)
Post Approval Changes [SUPAC]
Changes Being Effected in 30 Days (CBE-30)
Annual Report
Post marketing Reporting Requirements
Post approval Labeling Changes
Lifecycle Management
FDA Inspection and Enforcement Act
Form FDA 483
Establishment Inspection Report (EIR)
Warning Letters
Recalls, Seizure and Injunctions
9. Regulatory System in Canada (Health Canada)

New Drug Approval Process
Generic Drug Approval Process
10. Regulatory System in Europe (EMA)

Pharmaceuticals in the European Union
History of Drug Regulation in European Countries
Centralized Regulatory Authority of European Union (EU)
EUDRALEX: EU Pharmaceutical Legislation
European Medicines Agency (EMA)
Regulation of medicines in the European Union
Marketing Authorization
Centralized Procedure (CP)
Mutual Recognition Procedure (MRP)
Decentralized Procedure (DCP)
National Procedure
Types of Variations
11. Drug Registration with Rest of the World (ROW)

Introduction and Overview of Row regions and sub-regions
Registration with South-East Asian countries (ASEAN)
Registration with Latin America (Brazil, Mexico),
Registration with Middle East countries (GCC)
Registration in Emerging market (India, Russia, China, Japan, South Africa)
12. Dossier Preparation-Different Formats used Globally-

pCTD [Paper- CTD]
eCTD [Electronic CTD]
ACTD [ASEAN CTD]
NeeS [Non eCTD Electronic Submission]
13. Dossier preparation in pCTD and eCTD format

Introduction and Overview
CTD Format for Each Submission (US/EU)
Module 1 – Administrative and Prescribing Information
Module 2 – Common Technical Document Summaries
Module 3 – Quality Part-CMC
Module 4 – Nonclinical Study Reports
Module 5 – Clinical Study Reports
Electronic Submission
Planning your electronic submission
Regulatory requirements
Tool and Technologies Electronic Submission Process
NeeS: Non eCTD electronic Submission
· eCTD: Electronic submissions with xml backbone files
Electronic Submission Gateway (ESG)
14. Dossier preparation in ACTD format

Introduction and Overview
ACTD Format for ASEAN countries
PART-I – Administrative and Prescribing Information
PART-II – Quality Part-CMC
PAR-III – Nonclinical Study Reports
PART-IV – Clinical Study Reports
15. ICH Quality Guidance’s and its importance

Overview of –
ICH Q1 – Stability studies
ICH Q2 – Analytical Method Validation
• ICH Q3 – Impurities
• ICH Q4 – Pharmacopoeias
ICH Q5 – Quality of Biotechnological Products
• ICH Q6 – Specifications
ICH Q7 – Good Manufacturing Practice
ICH Q8 – Pharmaceutical Development
ICH Q9 – Quality Risk Management
ICH Q10 – Pharmaceutical Quality system
ICH Q11 – Development and Manufacture of Drug Substances(QbD)
16. 21CFR Part 11 guidance and its importance

17. Abbreviations

15 hours Classroom/Online Training

20,000 RS for Indian Students.

25,000 RS for NRI Students.

1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for eCTD/CTD : From 15000 RS per month to 20000 RS/23000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In eCTD/CTD : Progressive & Prosperous.
10. Is there any abroad Opportunities For eCTD/CTD : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good eCTD/CTD Jobs.

CERTIFICATION IN MEDICAL CODING — CMC

CMC Training Program

CMC – A Complete Job Oriented Training Program

CMC Certification is provided to candidates after attending 66 hours of training and clearing the various test conducted in the training program.

CMC is a job oriented training program covering all topics in Anatomy, Physiology and Pathology and ICD-10 CM, Basics of CPT-4 and HCPCS Coding.

✔ Anatomy, Physiology & Pathology Training Manual – Included

✔ Certification in Medical Coding Training Manual – Included

Topics Covered:

✔ Medical Terminology.

✔ Complete Anatomy, Physiology, Pathology, Clinical tests and Surgical Procedures.

✔ ICD-10 CM General Coding guidelines, conventions and coding for acute and chronic conditions and late effect, Impending and Pressure ulcer stages Coding.

✔ ICD- 10 CM Chapter Specific Guidelines including all the chapters like Fracture, Laceration, Poisoning Coding

✔ Introduction CPT-4 Procedure Coding Terminologies, HCPCS and Modifiers Coding.

✔ HIPAA Training.

✔ Revenue Cycle Management and CPC, CPC-A and CCS-P sample question pattern

Salient Features of CMC

✔ Comprehensive Training focused on Job Training and Placement.

✔ Complete ICD-10 CM Coding with Detailed Exposure to General Coding Guidelines and Chapter Specific Guidelines’ training with HIPAA compliance.

✔ CPT4 Procedural Coding, HCPCS and Modifiers Coding and RCM training with HIPAA compliance.

✔ Training methodologies and Placement process is in par with ISO 9001:2008 certification standards.

✔ Anatomy and Physiology training through plenty of videos.

✔ Certification provided after successful completion of Coding Training

✔ Interview Training.

✔ Placement assurance after certification.

Course Duration : 45 Hours

Batches : Weekdays and Weekend Batch

Weekdays : Monday to Friday

Weekends : Saturday & Sunday

22,500 RS for Indian Students.

27,500 RS for NRI Students.

1. What is the Qualification For Doing the course : B. Tech, B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS
B. PT, B. Sc (Nursing), M. Sc (Nursing)
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Argus Medical Coding : From 30000 RS per month to 33000 RS/35000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Medical Coding : Progressive & Prosperous.
10. Is there any abroad Opportunities For Medical Coding : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Medical Coding Jobs.

MATERIOVIGILANCE

Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient’s health by preventing its recurrences.

  • Medical Device Course Overview
  • Introduction to Medical Devices Course
  • Scope for Medical Device Writing& Companies Offering
  • Differences B/W Devices and Drug Writing
  • Overview of MedDev Rev 4 Guidelines
  • Regulations of MDD and MDR
  • Overview of Clinical Evaluation Report
  • Overview of Other Medical Device Regulatory Documents
  • Claiming Equivalency to Medical devices
  • State of the Art
  • Appraisal and Writing Literature Summaries
  • Risk- Benefit Analysis
  • PMS and PMCF
  • Overview of IVDR

3 Types :
Weekend Batch : 3 Months
Weekdays Batch : 2 Months
Crash Course : 1 Month (Only On Personal/Urgent Basis)

15,000 RS for Indian Students.

20,000 RS for NRI Students.

1. What is the Qualification For Doing the course:
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Materiovigilance Job : From 20000 RS per month to 23000 RS/26000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Materiovigilance : Progressive & Prosperous.
10. Is there any abroad Opportunities For Materiovigilance : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Materiovigilance jobs.

MEDICAL COMMUNICATIONS

Medical communications are designed to stimulate awareness, discussion and procurement of new medical devices, drugs and treatments. Aimed at healthcare practitioners, buyers and stakeholders, it is a key aspect of pharmaceutical marketing.

Our training program includes the following components:

Audit of writing skills
About Medcomm Agencies
Blog articles
Infographics
Manuscript Writing
Tool and technique in Medical Writing
Detailing aids
Leave Behind Literature
Case reports
Advisory Board Meeting
Consensus document
Patient Education
Slide Kits – Training Modules
Slide Kits – Speaker Presentations
Post-meeting deliverables
KOL related communications
Insights/SMP/USP/Copywriting
White Papers
Freelancing
Networking

The program is covered in 9 sessions where you will be introduced to the practical aspects of medical writing over a period of 3 months.

The consultation fees is INR 10,000 for a group session.

1. What is the Qualification For Doing the course:
B.E, B. Tech, MCA, M. Tech.
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for AWS Job : From 25000 RS per month to 30000 RS/35000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In AWS : Progressive & Prosperous.
10. Is there any abroad Opportunities For AWS : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good AWS jobs.

COMPUTER SYSTEM VALIDATION

Computer System Validation (CSV) is the validation process used in regulated industries throughout the world to verify that a computerized system performs as it is designed to and that it maintains the  integrity of its data to ensure the safety and effectiveness of the product.

Detailed understanding on US FDA and EMEA requirements for Computer System Validation, Electronic
signatures, Part 11 compliance and signatures.
GAMP 5 Classification: Simplified! – Risk Management approach and principles for Part 11 compliance

Audit Trials:Demonstrating Data Integrity via Documentation and Audit Trails

Backup: Backup and Restoration procedures in detail.

Regulatory Requirements:In depth guidance on translating the regulatory authorities expectations and communicating with them
effectively through interactive sessions.

 

Total 20 hrs. (+ 5 hrs. Post-training queries support over TC)

20,000 RS for Indian Students.
25,000 RS for NRI Students

1. What is the Qualification For Doing the course :
B. Pharm, M. Pharm, Pharm. D, Ph. D, BDS, MDS, MBBS, BHMS, BAMS, B. PT
B. Sc (Nursing), M. Sc (Nursing).
2. Is this a certified course : Yes, you will be certified post completion of the course.
3. Average Pay Scale for Computer System Validation Job : From 20000 RS per month to 25000 RS/30000 RS depending on the company from which you get the offer letter.
4. Process of Joining : Every month Rise Trainings conduct batches you can join by enrolling your name and sharing the resume.
5. Is Placement or Job Assured for sure : Yes as long as you follow our 10 step method to achieve success. We support the students with utmost care.
6. Training on Safety Database Present : Yes hands-on training on software is provided.
7. Can I pay the fee in installments : Yes, only two installments are permitted. One before joining and the second before the course completion.
8. Payment of Fee Through : GPay/Phone Pe/Bank Account
9. How Is The Career Growth In Computer System Validation : Progressive & Prosperous.
10. Is there any abroad Opportunities For Computer System Validation : Yes, with good experience this chance of abroad opportunities through the companies or through the experience you gained and doing masters would enable more chances of getting good Computer System Validation jobs.

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