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Characteristics of dosage forms - part 2

Characteristics of dosage forms - part 2

Characteristics of dosage forms - Part 1

Characteristics of dosage forms - Part 1

Sterility of medicinal products in manufacturing - part 2

Sterility of medicinal products in manufacturing - part 2

Sterility of medicinal products in manufacturing - part 1

Sterility of medicinal products in manufacturing - part 1

Supplier management according to ISO 9001:2015 (Part 2)

Supplier management according to ISO 9001:2015 (Part 2)

Supplier management according to ISO 9001:2015

Supplier management according to ISO 9001:2015

How to determine auditor competence and evaluation - Clauses 7.4, 7.5 & 7.6

How to determine auditor competence and evaluation - Clauses 7.4, 7.5 & 7.6

How to determine auditor competence and evaluation - Clauses 7.1, 7.2 & 7.3

How to determine auditor competence and evaluation - Clauses 7.1, 7.2 & 7.3

How to conduct an audit according to ISO 19011:2018

How to conduct an audit according to ISO 19011:2018

How to conduct audit activities

How to conduct audit activities

How to prepare and conduct an audit

How to prepare and conduct an audit

How to monitor, review and improve an audit program

How to monitor, review and improve an audit program

How to ensure effective, efficient, and economically sound audit programs

How to ensure effective, efficient, and economically sound audit programs

How to assign responsibility for audits to team leaders

How to assign responsibility for audits to team leaders

How to choose and determine audit methods?

How to choose and determine audit methods?

How to define ISO 19011:2018 audit objectives, scope, and criteria

How to define ISO 19011:2018 audit objectives, scope, and criteria

How to implement an audit program according to ISO 19011:2018

How to implement an audit program according to ISO 19011:2018

How to establish an audit program according to ISO 19011:2018

How to establish an audit program according to ISO 19011:2018

Roles and responsibilities in ISO 19011:2018 audit programs

Roles and responsibilities in ISO 19011:2018 audit programs

Audit program risks and opportunities according to ISO 19011:2018

Audit program risks and opportunities according to ISO 19011:2018

How to set audit program objectives according to ISO 19011:2018

How to set audit program objectives according to ISO 19011:2018

How to manage an audit program according to ISO 19011:2018

How to manage an audit program according to ISO 19011:2018

What is design control?

What is design control?

7 Principles of auditing according to ISO 19011:2018

7 Principles of auditing according to ISO 19011:2018

Key concepts of ISO 19011:2018

Key concepts of ISO 19011:2018

Round table: Best practices in Quality Management that will impact your business

Round table: Best practices in Quality Management that will impact your business

How quality in MedTech became a driver of financial performance

How quality in MedTech became a driver of financial performance

CAPAs, events, and change control: Unlocking the potential for continuous quality improvement

CAPAs, events, and change control: Unlocking the potential for continuous quality improvement

Implementing Risk Based Approaches to Computerised System Validation

Implementing Risk Based Approaches to Computerised System Validation

Managing Quality Risks in Life Sciences. Case Study: Switch from paper based to electronic QMS

Managing Quality Risks in Life Sciences. Case Study: Switch from paper based to electronic QMS

GAMP: From theory to action in compliance management

GAMP: From theory to action in compliance management

Integrity of Quality and the Quality of Data Integrity

Integrity of Quality and the Quality of Data Integrity

Driving Quality Culture: The Power of Your People

Driving Quality Culture: The Power of Your People

Practical strategies to boost your QMS document compliance

Practical strategies to boost your QMS document compliance

Leverage your audits towards digital transformation

Leverage your audits towards digital transformation

Other physical contaminants: Intrinsic and inherent matter

Other physical contaminants: Intrinsic and inherent matter

Other contaminants: thermal, lightning, electromagnetic and physical

Other contaminants: thermal, lightning, electromagnetic and physical

Fundamentals and types of contaminants

Fundamentals and types of contaminants

Contamination control

Contamination control

Microbial contaminants

Microbial contaminants

Chemical contaminants

Chemical contaminants

Clause 8: Measurement, analysis and improvement

Clause 8: Measurement, analysis and improvement

Clause 7: Product realization (Part 1)

Clause 7: Product realization (Part 1)

Clause 7: Product realization (Part 3)

Clause 7: Product realization (Part 3)

Clause 7: Product realization (Part 2)

Clause 7: Product realization (Part 2)

ISO 13485:2016: Key Concepts (Part 5)

ISO 13485:2016: Key Concepts (Part 5)

ISO 13485:2016: Key Concepts (Part 4)

ISO 13485:2016: Key Concepts (Part 4)

ISO 13485:2016: Key Concepts (Part 3)

ISO 13485:2016: Key Concepts (Part 3)

ISO 13485:2016: Key Concepts (Part 2)

ISO 13485:2016: Key Concepts (Part 2)

ISO 13485:2016 -Medical devices — Quality management systems. Part II (Clause 6)

ISO 13485:2016 -Medical devices — Quality management systems. Part II (Clause 6)

ISO 13485:2016 -Medical devices — Quality management systems. Part II (Clauses 5.5 to 5.6)

ISO 13485:2016 -Medical devices — Quality management systems. Part II (Clauses 5.5 to 5.6)

ISO 13485:2016 -Medical devices — Quality management systems. Part II (Clauses 5.1 to 5.4)

ISO 13485:2016 -Medical devices — Quality management systems. Part II (Clauses 5.1 to 5.4)

ISO 13485:2016: Structure, Clauses and Key Concepts (Part 1)

ISO 13485:2016: Structure, Clauses and Key Concepts (Part 1)

Medical Device Quality Management System

Medical Device Quality Management System

ISO 13485:2016: Clauses 1 to 4

ISO 13485:2016: Clauses 1 to 4

Regulatory fundamentals of medical devices in the US (Part 1)

Regulatory fundamentals of medical devices in the US (Part 1)

ISO 13485:2016: Clause 0. Introduction

ISO 13485:2016: Clause 0. Introduction

Regulatory fundamentals of medical devices in the US (Part 3)

Regulatory fundamentals of medical devices in the US (Part 3)

Regulatory fundamentals of medical devices in the US (Part 2)

Regulatory fundamentals of medical devices in the US (Part 2)

Regulatory fundamentals of medical devices in the EU (Part 1)

Regulatory fundamentals of medical devices in the EU (Part 1)

Regulatory fundamentals of medical devices in the US (Part 3)

Regulatory fundamentals of medical devices in the US (Part 3)

Regulatory fundamentals of medical devices in the US (Part 2)

Regulatory fundamentals of medical devices in the US (Part 2)

Regulatory fundamentals of medical devices in the US (Part 1)

Regulatory fundamentals of medical devices in the US (Part 1)

Medical devices: Key concepts (II) and Classification

Medical devices: Key concepts (II) and Classification

Medical devices: Key concepts (I)

Medical devices: Key concepts (I)

ISO 14971:2019 Managing Risk for Medical Devices with FTA (Part 3)

ISO 14971:2019 Managing Risk for Medical Devices with FTA (Part 3)

ISO 14971:2019 Managing Risk for Medical Devices with FTA (Part 2)

ISO 14971:2019 Managing Risk for Medical Devices with FTA (Part 2)

ISO 14971:2019 Managing Risk for Medical Devices with FTA (Part 1)

ISO 14971:2019 Managing Risk for Medical Devices with FTA (Part 1)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 4)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 4)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 3)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 3)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 2)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 2)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 1)

Managing Risk for Medical Devices with Failure Modes and Effects Analysis (FMEA) (Part 1)

The Fundamentals of Medical Devices (Part 1)

The Fundamentals of Medical Devices (Part 1)

ISO 14971:2019 The Risk Management Process for Medical Devices part 4

ISO 14971:2019 The Risk Management Process for Medical Devices part 4

ISO 14971:2019 The Risk Management Process for Medical Devices (Part 3)

ISO 14971:2019 The Risk Management Process for Medical Devices (Part 3)

ISO 14971:2019 The Risk Management Process for Medical Devices (Part 2)

ISO 14971:2019 The Risk Management Process for Medical Devices (Part 2)

ISO 14971:2019 The Risk Management Process for Medical Devices (Part 1)

ISO 14971:2019 The Risk Management Process for Medical Devices (Part 1)

ISO 14971:2019 – Risk Management for Medical Devices part 4

ISO 14971:2019 – Risk Management for Medical Devices part 4

ISO 14971:2019 – Risk Management for Medical Devices (Part 3)

ISO 14971:2019 – Risk Management for Medical Devices (Part 3)

ISO 14971:2019 – Risk Management for Medical Devices (Part 2)

ISO 14971:2019 – Risk Management for Medical Devices (Part 2)

ISO 14971:2019 – Risk Management for Medical Devices part 1

ISO 14971:2019 – Risk Management for Medical Devices part 1

The Technical Writing Process (Part 2)

The Technical Writing Process (Part 2)

The Technical Writing Process (Part 1)

The Technical Writing Process (Part 1)

Good Manufacturing Practices for Medicinal Products EU GMP Part 1

Good Manufacturing Practices for Medicinal Products EU GMP Part 1

Good Distribution Practices GDP and the EU GDP Guideline Part 2

Good Distribution Practices GDP and the EU GDP Guideline Part 2

Effective Technical Writing in the Life Sciences

Effective Technical Writing in the Life Sciences

System Validation and Qualification Phases

System Validation and Qualification Phases

Good Distribution Practices GDP and the EU GDP Guideline Part 1

Good Distribution Practices GDP and the EU GDP Guideline Part 1

Introduction to Deviation Handling and Root Cause Analysis

Introduction to Deviation Handling and Root Cause Analysis

Introduction to Change Management

Introduction to Change Management

Introduction to Corrective and Preventive Actions

Introduction to Corrective and Preventive Actions

Good Documentation Practices (GDocP) for Electronic Systems

Good Documentation Practices (GDocP) for Electronic Systems

Data Integrity and Data Governance

Data Integrity and Data Governance

Good Documentation Practices (GDocP) for Paper-Based Systems

Good Documentation Practices (GDocP) for Paper-Based Systems

Introduction to Quality Risk Management

Introduction to Quality Risk Management

Complaints and Product Recalls

Complaints and Product Recalls

How can an eQMS provide value to your organization

How can an eQMS provide value to your organization

Electronic records and electronic signatures according to 21 CFR Part 11

Electronic records and electronic signatures according to 21 CFR Part 11

Electronic records and electronic signatures according to EU GMP Annex 11 for Computerised S

Electronic records and electronic signatures according to EU GMP Annex 11 for Computerised S

Management and control of records

Management and control of records

Document Control according to ISO 9001

Document Control according to ISO 9001

The Quality Management System (QMS) Pyramid Model

The Quality Management System (QMS) Pyramid Model

Quality and Quality Management System

Quality and Quality Management System

Six ways the Metaverse will help shape the Future of Pharma

Six ways the Metaverse will help shape the Future of Pharma

Designing the future of regulatory innovation: Artificial Intelligence Validation Consideration

Designing the future of regulatory innovation: Artificial Intelligence Validation Consideration

How to leverage Natural Language Processing (NLP) in the Life Sciences industry

How to leverage Natural Language Processing (NLP) in the Life Sciences industry

Smart Quality Mindset in Life Sciences organizations

Smart Quality Mindset in Life Sciences organizations

Smart Quality in Life Sciences: A new paradigm (Part 2)

Smart Quality in Life Sciences: A new paradigm (Part 2)

Smart Quality in Life Sciences: A new paradigm (Part 1)

Smart Quality in Life Sciences: A new paradigm (Part 1)

Top 5 Readings That Will Transform You into a Quality Booster

Top 5 Readings That Will Transform You into a Quality Booster

The Scilife Smart Quality

The Scilife Smart Quality

Performing Risk Management under MDR / IVDR

Performing Risk Management under MDR / IVDR

Quality Process Design by Scilife

Quality Process Design by Scilife

AI in Life Sciences: The path to empower us to superhuman performance!

AI in Life Sciences: The path to empower us to superhuman performance!

Embrace change control with Scilife!

Embrace change control with Scilife!

Scilife Webinar: Novosanis, the successful go-to-market journey of a certified ISO13485 medtech

Scilife Webinar: Novosanis, the successful go-to-market journey of a certified ISO13485 medtech

Scilife Webinar: Helius, the first medicinal cannabis company in New Zealand to be GMP certified

Scilife Webinar: Helius, the first medicinal cannabis company in New Zealand to be GMP certified

#IWD2022 - We Stand with You!

#IWD2022 - We Stand with You!

The successful go-to-market strategy of a certified ISO13485 medical device: Novosanis’ Journey!

The successful go-to-market strategy of a certified ISO13485 medical device: Novosanis’ Journey!

Scilife: Happy New Year 2022

Scilife: Happy New Year 2022

The Customer Centric approach to Healthcare Quality - Where quality meets customers

The Customer Centric approach to Healthcare Quality - Where quality meets customers

Stop drowning in CAPAs! Discover Scilife CAPA Module 🔬

Stop drowning in CAPAs! Discover Scilife CAPA Module 🔬

Quality Systems, Computer System Validation (CSV), and Data Integrity with Yves Dène

Quality Systems, Computer System Validation (CSV), and Data Integrity with Yves Dène

Data security of a cloud-based application in Life Sciences ☁️🚀

Data security of a cloud-based application in Life Sciences ☁️🚀

Continuous Improvement in a fast-growing Medical Device company

Continuous Improvement in a fast-growing Medical Device company

Deviations & Nonconformities Module 🔎

Deviations & Nonconformities Module 🔎

Scilife Document Control Module!

Scilife Document Control Module!

Keep track of printed forms & documents

Keep track of printed forms & documents

Risk management success: What does it look like for Life Science Companies...?

Risk management success: What does it look like for Life Science Companies...?

Scilife Platform for Life Sciences

Scilife Platform for Life Sciences

Scilife for Enterprise

Scilife for Enterprise

Scilife Support System

Scilife Support System

Scilife Onboarding and Data Import

Scilife Onboarding and Data Import

Scilife Story

Scilife Story

Scilife Values: Outside of the Box

Scilife Values: Outside of the Box

Scilife Values: Driven by Evidence

Scilife Values: Driven by Evidence

Scilife Values: All Hearts And Ears

Scilife Values: All Hearts And Ears

Scilife Values: Healthy inside-out!

Scilife Values: Healthy inside-out!

Scilife for Pharma & Biotech Companies

Scilife for Pharma & Biotech Companies

Scilife for Medical Devices Companies

Scilife for Medical Devices Companies

What powers you?

What powers you?