Post Graduation Diploma in Pharmaceutical Documentation
Post Graduate Diploma
In Thane
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
Start date
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
Reviews
Subjects
- Pharmaceutical documentation
- PDR
Teachers and trainers (1)
Rajashri Ojha
Teacher
Course programme
Additional information
Post Graduation Diploma in Pharmaceutical Documentation