Post Graduation Diploma in Pharmaceutical Documentation

Post Graduate Diploma

In Thane

₹ 15,000 VAT incl.

Description

  • Type

    Post Graduate Diploma

  • Location

    Thane

  • Class hours

    3h

  • Duration

    3 Months

  • Start date

    Different dates available

1)Introduction to Pharmaceutical Documentation profession
General principle, Quality Management System (QMS), Standard Operating Procedures (SOP’S), Batch manufacturing record & Master formula plan
2)Training & Qualification of Person
Introduction, Good documentation tips, Reasons for documentation
3)Validation Documentation
Validation master plan, Validation protocol, Certificate of analysis Validation report
4)Documentation control
5)Product development documentation
Specification for drug product & Stability testing and documentation
6)PIC/S Guidance for Documentation

Important information

Documents

  • 3m Advanced PG Diploma in Pharma Documentation_Raaj GPARC.pdf

Facilities

Location

Start date

Thane (Mahārāshtra)
See map
400609

Start date

Different dates availableEnrolment now open

About this course

Understand the importance of good documentation and how to apply it in pharmaceutical industry.
Recognize and understand the key documents involved in Chemistry and Manufacturing Control (CMC) processes.
Understand the role of these key documents and how they link together within the Quality Management System.
Understand how product specifications are determined.
Gain the skill and knowledge necessary to meet current regulatory expectations
Understand the documentation requirements with regards to storage of materials, sampling procedures, stability testing and qualification and training of personnel.
Know the key documents associated with laboratory controls.
Feel more comfortable with documentation on a daily basis.
Improve the current approach to documentation within your company.
Defines specifications and procedures for all materials and methods of manufacture and control.
Ensures all personnel know what to do and when to do it.
Ensure that authorized persons have all information necessary for release of Product.
Ensures documented evidence, traceability, provide records and audit trail for investigation.
Ensures availability of data for validation, review and statistical analysis

All those who have completed their Graduation or Post Graduation/Pharma / PhD are eligible to enroll for the course.
Professionals from pharmaceutical companies.
QC/QA Managers and Staff
Documentation Department.
Research Chemist, Quality Control Chemist & CRO’s involved in Documentation

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Reviews

Subjects

  • Pharmaceutical documentation
  • PDR

Teachers and trainers (1)

Rajashri  Ojha

Rajashri Ojha

Teacher

Course programme

1)Introduction to Pharmaceutical Documentation professionGeneral principle, Quality Management System (QMS), Standard Operating Procedures (SOP’S), Batch manufacturing record & Master formula plan2)Training & Qualification of PersonIntroduction, Good documentation tips, Reasons for documentation3)Validation DocumentationValidation master plan, Validation protocol, Certificate of analysis Validation report4)Documentation control5)Product development documentationSpecification for drug product & Stability testing and documentation6)PIC/S Guidance for Documentation

Additional information

or further enquiries or Prospectus, write to or call us on: localhost, info@rajgprac.com , raajgprac@gmail.com, rajashrio@gmail.comwww.raajpharmaelearning.com,@mtnl.net.in Phone no: 9819488208 / 9821144706 / 022 65619030 /022 25445541

Post Graduation Diploma in Pharmaceutical Documentation

₹ 15,000 VAT incl.