PDA-PIC/S Training Course

Program Agenda

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Thomas Arista

Data Integrity and APIS The Regulatory Perspective

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Thomas Arista & Cormac Dalton

Case Study 1: Laboratory / Manufacturing Data Integrity

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Thomas Arista & Cormac Dalton

Case Study 3: API Manufacturer Laboratory

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Ariel Cruz Figueroa

Regulatory Expectations for Contract Manufacturers and the Sponsor

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Cormac Dalton & Anil Sawant

Challenges from the API Industry Perspective

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Maryann Gribbin

What is Data Integrity? Case Studies Laboratory Systems Manufacturing Systems

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Susan Laska

A General Overview of PIC/S

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Susan Laska

General Overview of the Inspection Program

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Susan Laska

Regulatory Challenges during Planning/Inspections of (API) Manufacturing Sites

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Libia Lugo

NEW | Commonly Identified Non-Compliance Deficiencies Found at (API) Manufacturing Sites (US FDA Perspective)

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Libia Lugo & Anil Sawant, PhD

NEW | Case Study 2: Production Documentation-Investigation of Deviations

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Edwin Rivera Martinez

Background and Introduction to ICH Q7-General Overview

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Edwin Rivera Martinez

Link to the ICH Quality Paradigm

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Edwin Rivera Martinez

International Regulations/GMP Guidance on APIs and Supply

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Anil Sawant, PhD

NEW | Quality Culture and Code of Conduct

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Anil Sawant, PhD

Strengthening the Internal Audit Program to Assure Data Integrity, The Industry Perspective

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