Proaxive

Training

Computer System Validation

Computer System Validation

This training focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The core elements of computer validation program will be emphasized.

Topics to be discussed include:

SDLC (System Development Life Cycle) Process
Computer System Validation fundamentals
Verification vs Validation
The Validation Regulations
Overview of 21 CFR Part 11
Review of Part 11 implication in regulations and guidance
21 CFR Part 211
21 CFR Part 820
Overview of GAMP 5 (Good Automated Manufacturing Practices)
Overview of IEC 62304 – Medical Device Software Lifecycle Process
URS, FRS, Design Specification
Risk Assessment in Computer System Validation
Validation Plans and Master Validation Plans
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ) and Performance Qualification (PQ)
Requirements Traceability Matrix
Validation Summary Report
SOP’s for system operation and maintenance

FDA Regulatory Affairs

This training focuses on understanding of the regulatory requirements necessary to bring Drugs, Biotech Products and Medical Devices to market in the US. .

Topics to be discussed include:

Overview of FDA and Drug Development
IND (Investigational New Drug) Application
NDA (New Drug Application)
Module 1 – Administrative and Prescribing Information
Module 2 – Common Technical Document Summary
Module 3 – Quality
Module 4 – Nonclinical Study Reports
Module 5 – Clinical Study Report
FDA Medical Device Regulation
The 510 (k) Premarket Notification – Traditional, Special, Abbreviated, De Novo
The PMA (Pre Market Approval) Application

Medical Device QMS

This training focuses on understanding design controls for medical devices in accordance with current FDA regulations and learning how an effective Process Validation system is a critical requirement towards a risk-based approach to compliance and product safety. .

Topics to be discussed include:

21 CFR Part 820 – QSR scope, definitions and requirements
Class I, II, III Medical Device Classification
Overview of ISO 14971:2007 and EN ISO 14971:2012 Risk Management standards
Discussion of Various Document types – Product Specification, Marketing Specifications, Design Reviews, Design Verification Plan, Design Verification Report, Design Validation Plan, Design Validation Report, Test Method Validation, Design Transfer Plan, Risk Analysis, Design History File
Discussions on V&V Strategies, statistical methods, Reliability Assessment, Test Method Validation
Risk Evaluation Tools and Methods
FMEA/FMECAs
FTA
PHA
HACCP
Process Validation Compliance Requirements
Process Validation Elements – Validation Master Plan, Equipment Installation, Operation and Performance Qualifications (IQ, OQ, PQ), Validation Reports
Use of Statistical Tools in Validation – Process Capability, T-tests, ANOVA, Data Types

Pharmaceutical Drugs and Biologics

This training focuses on understanding of the requirements of validation for both small molecule (pharmaceuticals) and Biologic products. This training reflect the current requirements and guidance’s published by the European Medicines Agency, FDA and International Conference on Harmonization .

Topics to be discussed include:

Introduction to Process Validation
Process Validation Definition
Types of Process Validation – Prospective, Retrospective, Concurrent
Facility Validation
Cleaning Validation
Processing Equipment Validation
Sterilization Validation
Packaging Validation
Basics of Statistical Tools
Process Validation Compliance
Supplier Process Validation
Laboratory Equipment Validation and Qualification Process
Equipment Categories – Group A, Group B, Group

Training

Computer System Validation

Topics to be discussed include:

FDA Regulatory Affairs

Topics to be discussed include:

Medical Device QMS

Topics to be discussed include:

Pharmaceutical Drugs and Biologics

Topics to be discussed include:

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