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Topics

Data Integrity

Quality Management

Medical Device

GxP Regulations

Document Management

Quality Assurance (QA)

Audit Management

Change Management

Records Management

Supplier Management

21 CFR Part 11 compliance for electronic records and signatures

21 CFR Part 11 compliance for electronic records and signatures

An introduction to medical device risk management: ISO 14971:2019

Quality Management

An introduction to medical device risk management: ISO 14971:2019

Clinical Trial Phases

GxP Regulations

Clinical Trial Phases

Complaints and Product Recalls

Quality Management

Complaints and Product Recalls

Data Integrity and data governance

Data Integrity and data governance

Document control according to ISO 9001

Document Management

Document control according to ISO 9001

Effective technical writing in life sciences

Quality Assurance (QA)

Document Management

Effective technical writing in life sciences

Electronic Common Technical Document (eCTD)

GxP Regulations

Electronic Common Technical Document (eCTD)

Electronic records and electronic signatures according to EU GMP Annex 11 for computerized systems

Electronic records and electronic signatures according to EU GMP Annex 11 for computerized systems

EU MDR - Medical Device Regulation

EU MDR - Medical Device Regulation

Fundamentals of Good Manufacturing Practices

GxP Regulations

Fundamentals of Good Manufacturing Practices

Good Clinical Practices (GCP): Introduction, background, and responsibilities

GxP Regulations

Good Clinical Practices (GCP): Introduction, background, and responsibilities

Good Clinical Practices (GCP): Protocol, case report, and initial documentation

GxP Regulations

Good Clinical Practices (GCP): Protocol, case report, and initial documentation

Good Distribution Practices and the EU GDP guidelines (Part 1)

GxP Regulations

Good Distribution Practices and the EU GDP guidelines (Part 1)

Good Distribution Practices and the EU GDP guidelines (Part 2)

GxP Regulations

Good Distribution Practices and the EU GDP guidelines (Part 2)

Good documentation practices (GDocP) for electronic systems

Document Management

Good documentation practices (GDocP) for electronic systems

Good documentation practices (GDocP) for paper-based systems

Document Management

Good documentation practices (GDocP) for paper-based systems

Good Manufacturing Practices for Medicinal Products (EU GMP Part I)

GxP Regulations

Good Manufacturing Practices for Medicinal Products (EU GMP Part I)

How to minimize contamination in aseptic processing

GxP Regulations

How to minimize contamination in aseptic processing

Introduction to Audit Management

Quality Management

Audit Management

Introduction to Audit Management

Introduction to CAPA

Quality Management

Introduction to CAPA

Introduction to Change Management

Quality Management

Change Management

Introduction to Change Management

Introduction to deviation management and root-cause analysis

Quality Management

Introduction to deviation management and root-cause analysis

Introduction to Quality Assurance and Quality Management Systems

Quality Management

Introduction to Quality Assurance and Quality Management Systems

Introduction to Quality Risk Management

Quality Management

Introduction to Quality Risk Management

Introduction to system validation and qualification

GxP Regulations

Introduction to system validation and qualification

Managing risk for medical devices with FTA: ISO 14971:2019

Quality Management

Managing risk for medical devices with FTA: ISO 14971:2019

Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4

Quality Management

Medical Device QMS: ISO 13485:2016 Essentials from Clause 1 to Clause 4

Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6

Medical Device QMS: ISO 13485:2016 Essentials from Clause 5 to Clause 6

Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8

Quality Management

Medical Device QMS: ISO 13485:2016 Essentials from Clause 7 to Clause 8

Overview of the European Marketing Authorisation Applications

GxP Regulations

Overview of the European Marketing Authorisation Applications

Primary characteristics of sterile dosage forms

GxP Regulations

Primary characteristics of sterile dosage forms

Product life cycle of medical devices

Product life cycle of medical devices

QMS documentation hierarchy and how to implement it

Quality Management

QMS documentation hierarchy and how to implement it

Records management compliance with GxP guidelines

Records Management

Records management compliance with GxP guidelines

Risk-based audit practices under ISO 19011:2018: Competence and evaluation of auditors

Quality Management

Audit Management

Risk-based audit practices under ISO 19011:2018: Competence and evaluation of auditors

Risk-based audit practices under ISO 19011:2018: Conducting an audit

Quality Management

Audit Management

Risk-based audit practices under ISO 19011:2018: Conducting an audit

Risk-based audit practices under ISO 19011:2018: Key auditing concepts and principles

Quality Management

Audit Management

Risk-based audit practices under ISO 19011:2018: Key auditing concepts and principles

Risk-based audit practices under ISO 19011:2018: Managing an audit program

Quality Management

Audit Management

Risk-based audit practices under ISO 19011:2018: Managing an audit program

Risk management for medical devices with FMEA: ISO 14971:2019

Quality Management

Risk management for medical devices with FMEA: ISO 14971:2019

Risk management process for medical devices: ISO 14971:2019

Quality Management

Risk management process for medical devices: ISO 14971:2019

Stages of system validation and qualification

GxP Regulations

Stages of system validation and qualification

Sterile Medicinal Products

GxP Regulations

Sterile Medicinal Products

Sterilization methods: Filtration and chemical

GxP Regulations

Sterilization methods: Filtration and chemical

Sterilization methods: Heat, radiation, and electron beam

GxP Regulations

Sterilization methods: Heat, radiation, and electron beam

Supplier Management according to ISO 9001:2015

Supplier Management

Supplier Management according to ISO 9001:2015

The benefits of an eQMS for your organization

Quality Management

The benefits of an eQMS for your organization

The fundamentals of aseptic processing for sterile drug products

GxP Regulations

The fundamentals of aseptic processing for sterile drug products

The fundamentals of contamination control: Chemical and microbiological contaminants

GxP Regulations

The fundamentals of contamination control: Chemical and microbiological contaminants

The fundamentals of contamination control: Physical contaminants

GxP Regulations

The fundamentals of contamination control: Physical contaminants

The fundamentals of medical device QMS

Quality Management

The fundamentals of medical device QMS

The fundamentals of medical devices

The fundamentals of medical devices

The Journey of Medicine: From lab to patient in the EU

GxP Regulations

The Journey of Medicine: From lab to patient in the EU

The origins of GMP regulations in the GxP Industry

GxP Regulations

The origins of GMP regulations in the GxP Industry

The technical writing process

Quality Assurance (QA)

Document Management

The technical writing process

US FDA - Medical Device Regulations

US FDA - Medical Device Regulations