Pharmaceutical Guidance Complete Pharma Solution
- Change Control
- Hold Time Study Protocol
- CRITICAL AND MAJOR DEFICIENCIES
- GMP Deficiencies in Pharmaceutical Industry “Critical and Major deficiencies”
- INSPECTIONS/AUDITS
- ELECTRONIC RECORDS
- RESOURCES-THE QUALITY SYSTEMS MODEL
- MANUFACTURING-THE QUALITY SYSTEMS MODEL
- MANAGEMENT RESPONSIBILITY-THE QUALITY SYSTEMS MODEL
- CGMPS AND THE CONCEPTS OF MODERN QUALITY SYSTEMS
- EVALUATION ACTIVITIES – THE QUALITY SYSTEMS MODEL
- USFDA Guidance on Quality Metrics
- Quality Measures
- Change management As Per WHO TRS1019 Annex 3
- Quality Metrics in pharmaceutical industry
- REMEDIATION OF DATA INTEGRITY FAILURES
- Classification of data integrity deficiencies
- Out of Specification & Out of Trend Investigations as per MHRA
- TOOLS FOR QUALITY IMPROVEMENT PART – I
- Human Errors
- What are the different types of Quality Management systems (QMS)?
- What is future mapping?
- OUT OF SPECIFICATIONS (OOS)
- SOP for Quality Assurance Policy
- ASSESSMENT OF QUALITY RISK MANAGEMENT IMPLEMENTATION
- RISK MANAGEMENT METHODOLOGY – ICH Q9
- TABLE OF CONTENTS – QUALITY RISK MANAGEMENT -ICH Q9
- DRUGS AND COSMETICS ACT, 1940 FOR MEDICINE
- Validation Questions on cleaning validation (APICS)
- Cleaning process Control
- Market complaints and product recall
- SOP on Document Management System in Quality Assurance Department.
- EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS
- DOCUMENTATION IN PHARMACEUTICAL
- Cleaning validation Principle Appendix 3 (WHO Guideline)
- PERSONNEL HYGIENE
- Standard/non-standard processes
- Process validation scheme
- Process validation (Continuous process verification) for finished products
- Qualified Person
- DRUG DESIGN (AN OVERVIEW)
- CHANGE CONTROL
- Quality Management System
- HAZARD ANALYSIS OF CRITICAL CONTROL POINT (HACCP)
- Meanings of terms
- HACCP VALIDATION REPORT
- Interview Questions & Answers (Quality Assurance)
- Observations & Compliances response of GMP Inspections
- ANVISA – The Brazilian Health Surveillance Agency
- New Product Design and Development Process