CAPA Archives - EMMA International

Complaint Management

Complaint management systems are a necessary part of a Quality Management System. Complaint management is defined as any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. As outlined in 21 CFR 820.198, each manufacturer maintains complaint files and has a process for receiving, reviewing, and evaluating complaints. This must be done in a timely manner and be done by a formal complaint handling unit.

Corrective and Preventive Action

In addition to helping manufacturers make better products, corrective and preventive actions are important because the process is legally required by the FDA when making medical devices for the US market.

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QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?

Incorporating GDP through Lean Six Sigma

GDP – far-reaching within all GxP-compliant organizations, and yet it can be a challenging point for many during audits. GDP, or Good Documentation Practices, are essential to maintaining an effective QMS. In a previous blog post, we touched on GDP, ALCOA+, and recommendations for successful GDP practices. In this post, we’re going to take a deeper dive into GDP, the governing regulations, and tips on consistently maintaining GDP.

How does FDA regulate Complementary and Alternative Medicine

Ayurveda, which is a traditional system of medicine, originated more than 3000 years ago. This field of medicine pays larger emphasis on building strength of mind and body to cope with different kinds of stressors and infections.[i] There are studies which suggest that ayurveda can reduce pain, manage with symptoms of type 2 diabetes, etc.

FDA Warning Letters Are Public Information

For a medical device organization, a Warning Letter from the FDA is the worst kind of publicity. It is an open disclosure of how poorly your organization complied with specific regulatory requirements.

Role Definition for Team Success

Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.

Regulation of MedTech Products in India

Earlier this month, the Ministry of Health and Family Welfare, Government of India released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“Bill”).[i] This Bill overhauls the pre-independence legislation enacted by the Central Legislative Assembly, the Drugs and Cosmetics Act, 1940,[ii] (“D&CA”) which is the primary legislation for regulation of drugs, biologics and medical devices at the moment.

Internal Audit Readiness

Internal audits within the life science industry serve to evaluate a company’s internal controls to ensure compliance with laws and regulations for the safety and efficacy of products or services. Internal audits are performed by qualified individuals who do not have direct responsibility for the area that is being audited. Audits may be an anxiety-inducing word but can become much more inviting through efficient preparation, and results from an audit may even be used as powerful tools to continuously improve on one’s QMS.

When To Write A CAPA

A Corrective and Preventative Action (CAPA) is a tool utilized in order to address an issue or a potential issue with a product or process. According to the FDA “The purpose of the corrective and preventive action subsystem is to collect information,…

Human Error in Corrective and Preventative Actions

‌ When an error occurs, corrective and preventative actions are developed to help strengthen the quality...

CAPA