Post Graduation Diploma in Pharmaceutical Documentation

Raaj GPRAC
In Thane

Rs 15,000
You can also call the Study Centre
98191... More
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Important information

  • Post Graduate Diploma
  • Thane
  • 3 hours of class
  • Duration:
    3 Months
  • When:
    Flexible
  • Credits:
Description

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 Venues

Where and when

Starts Location Timetable
Flexible
Thane
400609, Maharashtra, India
See map

Frequent Asked Questions

· What are the objectives of 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

· Who is it intended for?

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

What you'll learn on the course

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

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