Professional Documents
Culture Documents
Ramesh Babu
pg. 1
TOPICS FOR TRAINING
QUALITY MANAGEMENT SYSTEM
☐ 483 Observations - Impact
☐ Root Cause Analysis
☐ Human Errors – Control
☐ 21 CFR Recommendations
☐ Acceptable Quality Level (AQL)
☒ Adverse Reaction Effects
☐ GMP Airlocks and Change rooms
☐ ALCOA – Tool for Quality
☐ Annual Product Quality Review (APQR)
☐ Audit Trails - Importance
☐ Batch Failure Investigation
☐ Bio contamination Controls
☐ Biofilm Control Measures
pg. 2
TOPICS FOR TRAINING
QUALITY MANAGEMENT SYSTEM
☐ Qualified Person Requirement
☐ Internal Audits
☐ Interviewing QC/QA personnel
☐ ISO 9001 Requirements
☐ ISO 14001 – Requirements
☐ ISO 18001 – Requirements
☐ OOS – Investigation sequence
☐ Organogram and Job Responsibilities
☐ Pass boxes – classified areas
☐ Periodic Review and Compliance
☐ Pharma Manual
☐ Contamination Control
☐ Excipients and their Usage
pg. 3
TOPICS FOR TRAINING
QUALITY MANAGEMENT SYSTEM
☐ Color codes – Gas
☐ Avoid GMP Errors
☐ Concept of cGxP
☐ Container Closure system for packing
☐ Controlled area vs. classified area
☐ Clean Room garments
☐ UV Lamps
☐ Dynamic Pass Box vs. Static Pass Box
☐ Fogging vs. Fumigation
☐ Routes of Drug Administration
☐ Storage conditions - Requirements
☐ Chemical Indicators – Sterilization
☐ DMF – Contents, Types
pg. 4
TOPICS FOR TRAINING
QUALITY MANAGEMENT SYSTEM
☐ Lubricants proportion
☐ Direct compression Methodology
☐ Mechanism of Drug Release for OSD
☐ Implementation of cGMP aspects as per USFDA requirements
☐ Personnel Hygiene Standards
☐ Good Documentation Practices (GDPs)
☐ Good Engineering Practices (GEPs)
☐ Good Laboratory Practices (GLPs)
☐ Standard Operating Procedure Management
☐ Training Management
☐ Medical Examination
☐ Handling of Returned Goods/Products
☐ Handling of Rejected Products
VALIDATION PRACTICES
☐ Approaches to Validation and Re-Validation
☐ Improve Water System Efficiency
☐ Alarm Challenge Test
☐ Cleaning Validation
☐ Cleaning Method Validation
☐ Chlorination of Water
☐ Basics of HVAC
☐ Basics of Cleaning Validation
☐ Process Validation – Essential elements
☐ Autoclave validation
☐ Aseptic Media Fill Validation (AMFV)
☐ Analyst Qualification
pg. 5
TOPICS FOR TRAINING
VALIDATION MANAGEMENT
☐ Computer System Validation
☐ RADs and Diffusers in Controlled Areas
☐ GAMP 5 Requirements
☐ Re-validation concept
☐ Dead leg Calculation and Design Requirements
☐ Depyrogenation vs. Dry Heat Sterilization
☐ Basic Design concepts –Sterile Facility
☐ Design Qualification
☐ Calibration vs. Verification
☐ Qualification vs. Validation
☐ Z-Value – Biological Indicators
☐ Sterilization vs. Depyrogenation
☐ Selection of Mesh Sizes and Calculations
VALIDATION MANAGEMENT
☐ Password policy, Data Backup, Storage-CS
☐ Personnel Gowning – Qualification
☐ Clean Room Qualification
☐ SAL and LOG reduction
☐ Sterility Validation
☐ Temperature and Humidity Mapping
☐ Reynolds Number – PW System
☐ Calculation of Air Changes
☐ Sampling in CV
☐ Sampling Plan Development
☐ Sanitation of Clean Room Areas
☐ Sanitation of RO Membranes
VALIDATION PRACTICES
☐ Smoke Study in Clean Rooms
☐ Computer System Validation
☐ Equipment Qualification
☐ Re-validation – Equipment and Process
☐ PQ – Equipment
☐ PQ – Biological Indicators
☐ Media Fill Validation – SVPs
☐ Media Fill Validation sterile APIs
☐ Validation of Sterilization Process at Low
Temperatures
☐ Sterile Injectables – Typical Facility Layout
requirements
☐ Biosafety vs. LAF
☐ Isolator Technology Usage
pg. 6
TOPICS FOR TRAINING
VALIDATION MANAGEMENT
☐ Heat Distribution study – DHS
☐ Heat Distribution study – DPO
☐ Validation Master Plan (VMP)
☐ HVAC Validation process
☐ HEPA Significance, Replacement policy
☐ Hold Time Study
☐ How to execute validation Protocols
☐ How to write Validation Protocol
☐ F0 Value and its significance
☐ Blend Uniformity – Contents
☐ Validation Importance Requirements
☐ Installation Qualification (IQ)
☐ Qualification of Calculator
VALIDATION MANAGEMENT
☐ How to reduce Validation Cost
☐ Heating Block Validation
☐ Restricted Access Barrier System (RABS)
☐ ISO 14644-1 Requirements
☐ NOEL and MACO Calculations – CV
☐ Non-sterile Process Validation
☐ Latest Biological Indicators Usage
☐ Analytical Method Validation (AMV)
☐ Biological Indicators usage and significance
☐ BFS and FFS Technology
☐ Process Validation – Review Requirements
☐ Verification Checks – HVAC System
VALIDATION GUIDANCE
☐ PW vs. DM Water
☐ Site Acceptance Test (SAT)
☐ Inspection of High Purity Water Systems
☐ GAMP – 5
☐ Validation of Processes
☐ Factory Acceptance Test (FAT)
☐ Facility Qualification
☐ Epoxy Flooring – Benefits
☐ Temperature sensors – Types
☐ Packing Machines – Types
☐ Stainless Steel Identification – Types
pg. 7
Mr . D.Ramesh Babu
CONTACT
242/3RT, Vijaya Nagar Colony, Masab Tank, Hyderabad-500057, India
M: +91-8247899827/7032597309
drameshglobal@gmail.com
pg. 8