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Consultants The FDA Group

WebConsultants. With a staff of 2,500 resources worldwide, over 225 of whom are former FDA, we are sure to have the appropriate professional (s) for your project. We're also always …

Actived: 9 days ago

URL: https://www.thefdagroup.com/consultants

Corrective and Preventive Action (CAPA): The Definitive Guide [2024]

WebSome high-level steps for CAPA might include: 1) Creating and submitting a request; 2) reviewing the request appropriately; 3) finalizing sources and building your …

Category:  Health Go Health

NH-ISAC, MDISS & FDA Announce New Medical Device …

WebIn an effort to improve data sharing and cybersecurity in medical devices, three national organizations have signed a new Memorandum of Understanding (MOU) …

Category:  Medical Go Health

Good Pharmacovigilance Practices (GVP): A Quick-Guide

WebGood Pharmacovigilance Practices (GVP): A Quick-Guide. Today, the World Health Organization (WHO) defines pharmacovigilance as the science and activities …

Category:  Health Go Health

Life Science Quality Assurance in 2020: 5 Key Trends

WebPrior research has indicated a growing shift toward performance-oriented goals for quality operations, which by our numbers, seem to be holding in 2020. 2. …

Category:  Health Go Health

Deviation Management in the FDA-Regulated Industries

WebDeviation management is the systematic process of identifying, documenting, investigating, and addressing any unexpected or unplanned events that …

Category:  Health Go Health

Inside FDA's Proposed Rule to Regulate LDTs

WebOn September 29, 2023, the FDA proposed a rule that would end the enforcement discretion policy for laboratory-developed tests (LDTs) by treating them as …

Category:  Health Go Health

THE COMPLETE GUIDE TO EU-MDR TRANSITION

WebThe olete uide To EU-MDR Transition TheFDA rouco • Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and …

Category:  Health Go Health

A Quick Guide to Clinical Evaluation Under EU-MDR

WebAccording to the MDR, a clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data …

Category:  Health Go Health

A Basic Guide to the Medical Device Single Audit Program

WebThe mission of the MDSAP is to leverage regulatory resources from multiple regions to manage an effective, efficient, and sustainable single audit program focused …

Category:  Health Go Health

The Differences Between GCP, GLP and GMP Audits

WebThe Differences Between GCP, GLP and GMP Audits. If your time is short: The major differences between the three types of audits are related to the progressive …

Category:  Health Go Health

Compounding Pharmacies and CGMP: A Primer

WebToday, CGMP regulations are the cornerstone of the Food, Drug and Cosmetic Act (FD&C) ( “The Act” ). CGMP provides a mechanism for drug manufacturers …

Category:  Food Go Health

Pre-Approval Inspection (PAI): An Expert Guide to Preparation

WebThe FDA conducts Pre-approval Inspections to assure that a manufacturing site named in a drug application can manufacture the product and that the data …

Category:  Health Go Health

Subscriptions The FDA Group

WebSubscription Services The FDA Group's Insider Newsletter. The FDA Group’s Insider Newsletter is a premium newsletter that delivers regulatory and compliance news, as …

Category:  Health Go Health

5 Benefits of Workforce Insourcing: A Guide for the Life Sciences

WebInsourcing with a third-party resourcing firm can facilitate the on-boarding of traditional hires as well as shorter-term project-specific arrangements. At The FDA …

Category:  Health Go Health

MDSAP Audits: A Starter Guide for Device Manufacturers

WebThe general concept of the MDSAP can be thought of as a dynamic relationship between manufacturers (Mfr), regulatory authorities (RA), and auditing …

Category:  Health Go Health

FDA Warning Letter & Inspection Observation Trends [Updated …

WebFDA Warning Letter & Inspection Trend Highlights: 2023. In FY2022, FDA issued 62 warning letters and 23 import alerts related to drugs, excluding compound …

Category:  Health Go Health

FDA’s Crackdown on OTC Manufacturers: A Guide to CGMP …

WebThe FDA’s recent and ongoing focus on over-the-counter (OTC) drugs and other health products intensified with the agency issuing warning letters to four …

Category:  Health Go Health

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