Post Graduation Diploma in Pharmaceutical DocumentationRaaj GPRAC
- Post Graduate Diploma
- 3 hours of class
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