Search results: fda

This seminar will provide a solid foundation in the approval and clearance processes for medical devices in the United States including the underlying legal and regulatory requirements and the 'general controls' applicable to all devices.

This course has been designed to provide an essential overview of the critical factors when working with the FDA (Food and Drug Administration).  For those short on time this course is for you, as you will receive a focused and comprehensive overview of the key strategic considerations when making applications to the FDA.  

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

Gain practical guidance on EU and FDA regulations for drug/device combination products, along with solutions to current challenges, in this comprehensive course.

Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.

This training course prepares professionals in pharmaceuticals, healthcare, and manufacturing to navigate regulatory inspections by major health authorities including the FDA, MHRA, WHO, and EMA.

This course covers the key concepts of computer systems validation and provides practical guidance on how to comply with the regulations applicable to the pharmaceutical industry.

Navigate global market access for medical device software with insights on international regulations, reimbursement strategies, and Health Technology Assessment (HTA) to improve your product’s chances of commercial success

This course provides essential guidance on navigating regulatory requirements and securing market authorisation for AI-based medical devices, covering key regulations, compliance strategies, and best practices for global market access.

This course will cover key terminology, the EU and USA regulatory framework, Good Manufacturing Practice (GMP) requirements including controls and validation, and consider Good Distribution Practice (GDP) and how to manage your supply chain.

This seminar will provide you with an understanding of cybersecurity and its increasing regulatory focus, and how to embed and apply state-of-the-art security in your existing processes to deliver safe and secure products and solutions.

This interactive training skills and processes in pharma course is ideal for anyone with responsibility for planning or delivering training in the pharma, device or animal health industries (includes face-to-face and virtual training).

This session will summarise the EU AI Act and its implications on the healthcare sector, including how to be compliant with the new regulatory framework.

This course will cover the key regulations used globally in human factors and usability engineering: the specific standards and guidances, methods, and the tools commonly used in medical device development.

This course focuses on the Regulatory and Quality Management System links to Process Validation for medical devices, and reviews the Installation Qualification, Operation Qualification and Performance Qualification Processes and how these fit with regulatory needs and technical documentation.

This training will equip attendees with the practical skills necessary to implement regulatory-compliant distribution and storage systems, ensuring both pharmaceutical integrity and patient safety.

Learn the essential regulatory requirements for post-market surveillance (PMS), post-market clinical follow-up (PMCF), and vigilance of digital health technologies, ensuring product safety, compliance, and continued value creation throughout the product lifecycle

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD).

Learn the critical regulatory requirements and best practices for obtaining market authorisation of Software as a Medical Device (SaMD) and Medical Device Software (MDSW) in global markets.

Gain essential knowledge in developing and managing Software as a Medical Device (SaMD) and Medical Device Software (MDSW), focusing on regulatory compliance, risk management, and lifecycle management to ensure safety and effectiveness.

Explore the applications and significance of molecular biology in the pharmaceutical industry, covering DNA, RNA, proteins, gene expression, biotechnology, drug discovery, personalised medicine, and the latest breakthroughs like CRISPR-Cas9 and mRNA vaccines.

This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and a brief review of key FDA requirements.

In this talk, explore the fundamental concepts, techniques, and processes that make up the backbone of biomanufacturing, pharmaceutical production, and biotechnology.

This course covers Good Clinical Practice (GCP) principles, ensuring participants understand the ethical and regulatory foundations of clinical research, including integrity, safety, consent, data management, and compliance.