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Whitepapers

Clinical investigations under MDR: Key insights and practical experiences

Achieving Laboratory Compliance

Innovations in ATMP: State of the industry in 2024

Ensuring compliance and quality in Pharmacovigilance

Organic and Mutagenic Impurities in Pharma

Standards and Regulations for Software used in Medical Devices

IVDR Extension: What does this mean for you?

Clinical Evidence for IVDs under IVDR

GAMP 5 Software Validation Approach for GMP, GCP and GLP regulations

Mobile Health on the Rise: Exploring the Regulatory Landscape for Reimbursement

The One Vigilance Strategic Roadmap to corporate excellence

The key role of RA in pharma: from drug development to commercialization

New GMP Facility Qualification: Set-up, Process and Best Practices

State-of-the-art literature review: Kick Off the Clinical Evaluation of your Medical Device

Clinical Evaluation for medical devices under the Medical Device Regulation

Medical Devices: The Pathway from Idea to Patient under MDR

EU GMP: How to import your products into the EU?

ICH Stability Studies on Pharmaceuticals: the latest guidelines and methods

Digital Health - Exploring the landscape and future opportunities

From V-model to Agile

A complete guide to Computer System Validation (CSV)

GAMP categories for computerized systems: what are they and what are they for?

Cell by Design: Why a practical framework is key to the R&D process of any cell-based ATMP

Analytical method validation: A validated process control method to determine cell density

Data integrity in the pharmaceutical industry

Mobile applications and compliancy

Technology Transfer Needs a Lingua Franca

Technology transfer: trends, facts and succes factors

Quality by design methodology in the pharmaceutical industry:n what, why and how?

A critical look at Annex 1: Manufacture of Sterile Medicinal Products

Checklists

Checklist 21 CFR Part 11: does your system comply?

Checklist Eudralex Volume 4 Annex 11

Compliance checklist ISO 13485:2016

Document checklist ISO 13485:2016 implementation

Checklist MDR implementation

Flyers

A quality-focused process development roadmap for ATMPs

QbD, your partner in medical devices

QbD, your partner in great quality management

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From Paper to Practice: Technical Documentation Essentials for Medical Device Software
Webinar on demand - From Paper to Practice: Technical Documentation Essentials for Medical Device Software
Webinar (4)
Webinar on demand - Drug-Device Combination Products and Article 117
Webinar (3)
Webinar on demand - Evidence Throughout the Lifecycle: Integrating Clinical Needs into Design & Documentation
Clinical investigations under MDR
Clinical investigations under MDR
Webinar (2)
Webinar on demand - From Requirements to Code: Streamlining Your Medical Device Software Development Cycle
From Paper to Practice: Technical Documentation Essentials for Medical Device Software
Webinar on demand - From Concept to Market: Comprehensive Market Access Strategies for Medical Device Software
Webinar MDSW: intro
Webinar on demand - Getting Started: Overcoming Initial Obstacles in Medical Device Software Development
Achieving Laboratory Compliance
Achieving Laboratory Compliance
CPHI Milan
CPHI 2024 MILANO  
Whitepaper social image
Innovations in ATMP: State of the Industry in 2024
One Vigiliance - ensuring compliance and quality in pharmacovigilance (1)
Organic and Mutagenic Impurities in Pharma
ONE Vigilance Ensuring Compliance and Quality in Pharmacovigilance
Ensuring compliance and quality in Pharmacovigilance
Standards-and-Regulations-for-Software-Used-in-Medical-Devices---QbD-Group
Standards and regulations for Software used in Medical Devices
Whitepaper social image
Clinical Evidence for In Vitro Diagnostics under IVDR
webinar - ivdr extension
webinar on demand - IVDR Extension Explained: Tips & Strategies
Whitepaper social image-IVDR
IVDR Extension: What does this mean for you?
Global Compliance Free wp
GAMP 5 Software Validation Approach for GMP, GCP, and GLP regulations
Next-generation Bio-Pharmacovigilance The ONE-VIGILANCE Strategic Roadmap to Corporate Excellence - V02 (1)
The One Vigilance Strategic Roadmap to corporate excellence

Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.