Mr. D.

Ramesh Babu

242/3RT, Vijaya Nagar Colony, Masab Tank, Hyderabad-500057, India

M: +91-8247899827/7032597309
[email protected]

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

QUALITY MANAGEMENT SYSTEM

☐ Total Productivity Management
☐ Continuous Training
☐ Technology Transfer
☐ Re-processing vs. Re-working
☐ Product Registration
☐ Mix-up and Contamination controls
☐ Quality Manual
☐ Identification of contaminants in sterile area
☐ Housekeeping Requirements
☐ OOT vs. OOS
☐ Incident Report vs. Deviation Note
☐ Humidity vs. Relative Humidity
☐ Selection of Detergents for Cleaning

GUIDANCE AND GOOD PRACTICE

☐ CAPA Implementation
☐ Change Control Management
☐ Audits Checks Points
☐ FBD Finger bags – Usage, Maintenance
☐ Current Good Manufacturing Areas (cGMP)
☐ Data Integrity -21 CFR
☐ Critical and Non-critical areas
☐ Vendor Audit Checks
☐ USFDA Audit Preparation – Quality Control
☐ Membrane Filters Usage and Maintenance
☐ Tablet compression – Handling Defects
☐ Line clearance Checks

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

QUALITY MANAGEMENT SYSTEM

☐ Planning and execution of internal audits
☐ GMP Audit preparedness
☐ Preparation of APQR
☐ Preparation of BMR/MFR
☐ Preservatives and their concentrations
☐ Cross contamination controls
☐ Microbial contamination controls
☐ Qualification of vendors – RM/PM
☐ Sampling during PV
☐ Process Analytical Technology (PAT)
☐ Product Recall
☐ Quality by Design (QbD)
☐ Quality Management System (QMS)

GUIDANCE AND GOOD PRACTICE

☐ Quality Inspection
☐ Quality Risk Assessment
☐ Market Complaints
☐ Optimum usage of Coating Pan
☐ Buffer Preparation and Storage Area Controls
☐ Biosimilars and their importance
☐ Binder Preparation Requirements
☐ Weighing Practices
☐ Maintenance of Aseptic Processing areas
☐ Dry powder Injections – RH and Temperature
☐ Risks – TSE and BSE
☐ Alarm controls

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

QUALITY MANAGEMENT SYSTEM

☐ Electronic Batch Records
☐ FDA 483 Form and Warning Letters
☐ Fish Bone Analysis
☐ Good Documentation Practices (GDP)
☐ GMP – 21 CFR 210 & 211
☐ GMP Checks – Equipment, Filling& Packing,
Personnel, Premises, Process validation,
Sanitation and Hygiene, Water supply system,
weighing and dispensing, Validation,
Qualification
☐ Good Data Management System
☐ Site Master File (SMF)
☐ Preparation for FDA Inspection
☐ Corrective Action and Preventive Action
(CAPA)

GUIDANCE AND GOOD PRACTICE

☐ Schedule M Requirements
☐ Penicillin vs. Non-penicillin Manufacturing
☐ Environmental Monitoring (Trend Analysis)
☐ Failure Investigation
☐ QA vs. QC
☐ Hand Disinfectants – Usage
☐ Protection of Light sensitive Products
☐ Skill Matrix
☐ AHU Operation Policy
☐ Control Fungal counts in Classified Areas
☐ Visual Inspection Requirements
☐ Pressure differentials – Importance

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

QUALITY MANAGEMENT SYSTEM

☐ Control Samples
☐ Status Labelling
☐ Finished Product Batch Release
☐ Document Management
☐ Mock Recall
☐ Handling of Regulatory Inspections
☐ Identification of Gaps for Training Needs
☐ Preparation of Training Schedule/Planner
and Scheduling
☐ How to face Regulatory and Customer Audits
☐ Conducting Mock Audit(s)
☐ Facilitation for audit Preparedness

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
[email protected]
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