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ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity

ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity

Regular price €49,00 EUR

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Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1

Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1

Regular price €129,00 EUR

Regular price Sale price €129,00 EUR
Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Regular price €129,00 EUR

Regular price Sale price €129,00 EUR
Audit Trail Review Step-by-Step – The Definitive Operational Guide for QC and Manufacturing

Audit Trail Review Step-by-Step – The Definitive Operational Guide for QC and Manufacturing

Regular price €49,00 EUR

Regular price Sale price €49,00 EUR
How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide

How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide

Regular price €49,00 EUR

Regular price Sale price €49,00 EUR
Computer Software Assurance (CSA) – Operational GxP Guide

Computer Software Assurance (CSA) – Operational GxP Guide

Regular price €99,00 EUR

Regular price Sale price €99,00 EUR
Contamination Control Strategy (CCS) – Operational Guide according to EU GMP Annex 1

Contamination Control Strategy (CCS) – Operational Guide according to EU GMP Annex 1

Regular price €129,00 EUR

Regular price Sale price €129,00 EUR
Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN

Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN

Regular price €49,00 EUR

Regular price Sale price €49,00 EUR
GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR
PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them

PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them

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Regular price Sale price €49,00 EUR
ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure

ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure

Regular price €89,00 EUR

Regular price Sale price €89,00 EUR
Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Regular price €139,00 EUR

Regular price Sale price €139,00 EUR
GMP Pharmacopoeias Compared: Operational Management of USP – Ph. Eur. – JP – BP Divergences in GxP Audits

GMP Pharmacopoeias Compared: Operational Management of USP – Ph. Eur. – JP – BP Divergences in GxP Audits

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR
Pharmacopeias and GMP Audits: Operational Management of USP, Ph. Eur. and Multi-Regional Compliance During Inspections

Pharmacopeias and GMP Audits: Operational Management of USP, Ph. Eur. and Multi-Regional Compliance During Inspections

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR
GMP Pharmacopeias – Impurities and Critical Assays: Operational Multi-Region Management ICH vs USP vs Ph. Eur.

GMP Pharmacopeias – Impurities and Critical Assays: Operational Multi-Region Management ICH vs USP vs Ph. Eur.

Regular price €149,00 EUR

Regular price Sale price €149,00 EUR
A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies

A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies

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Regular price Sale price €149,00 EUR

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ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity

ALCOA+ & Data Governance – The Definitive Operational Guide for Pharmaceutical Data Integrity

Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1

Aseptic Process Simulation (Media Fill) – Practical Guide according to EU GMP Annex 1

Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Internal GMP Audits: how to make them effective, risk-based, and defensible during AIFA/FDA/EMA inspections

Audit Trail Review Step-by-Step – The Definitive Operational Guide for QC and Manufacturing

Audit Trail Review Step-by-Step – The Definitive Operational Guide for QC and Manufacturing

How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide

How to Prepare for a PIC/S Inspection – Operational Audit-Ready Guide

Computer Software Assurance (CSA) – Operational GxP Guide

Computer Software Assurance (CSA) – Operational GxP Guide

Contamination Control Strategy (CCS) – Operational Guide according to EU GMP Annex 1

Contamination Control Strategy (CCS) – Operational Guide according to EU GMP Annex 1

Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN

Data Integrity in QC Labs – HPLC, GC, Empower, LIMS, ELN

GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

GMP Deviations & CAPA: Effective Implementation and Audit Defensibility (EU GMP, FDA, AIFA, ICH Q10)

PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them

PIC/S PI Documents, Aide-Memoires and Operational Guidelines: How to Read, Interpret and Apply Them

ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure

ICH Efficacy Guidelines E – Clinical Studies, GCP, E6(R3) & Global Structure

Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

Extractables & Leachables (E&L) GMP – Risk-Based Operational Guide for Defensible Decisions in FDA/EMA Audits

GMP Pharmacopoeias Compared: Operational Management of USP – Ph. Eur. – JP – BP Divergences in GxP Audits

GMP Pharmacopoeias Compared: Operational Management of USP – Ph. Eur. – JP – BP Divergences in GxP Audits

Pharmacopeias and GMP Audits: Operational Management of USP, Ph. Eur. and Multi-Regional Compliance During Inspections

Pharmacopeias and GMP Audits: Operational Management of USP, Ph. Eur. and Multi-Regional Compliance During Inspections

GMP Pharmacopeias – Impurities and Critical Assays: Operational Multi-Region Management ICH vs USP vs Ph. Eur.

GMP Pharmacopeias – Impurities and Critical Assays: Operational Multi-Region Management ICH vs USP vs Ph. Eur.

A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies

A Guide to Validation Managers and Calibration Managers in Pharmaceutical Companies

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