All Blog Posts Tagged 'FDA' (145)

What Does a FDA 510( k) Clearance mean?

Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product…

Production and Process Controls (P&PC) are one of the key capabilities necessary for medical device companies to consistently and effectively produce safe and effective products.

Because Production and Process Controls are so critical they are one of the major subsystems emphasized in inspections by the FDA.

Failure to adequately implement Production and Process Controls (P&PC) can lead to disaster for your company or even worse for your customer. And…

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential…

Documented Part 11 training, as with any FDA regulation, is required for staff members who have responsibilities within the scope of the regulation.

Understanding the requirements of Part 11 is critical to compliance with the regulation. Knowledge of regulatory requirements is an exercise in project management, and avoidance of non-compliance penalties.

• History and Overview
• Subpart A: General Provisions
• Subpart B: Electronic…

21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs.

This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.



This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to…

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.



The focus of most validation work is on the methodology, the standard operating procedure…

This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.

Instrumental liquid chromatography, either as HPLC or UPLC, are common techniques in laboratories that are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals.



The focus of most validation work is on the methodology, the standard operating procedure…

Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.

Well written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.



This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well…

CAPA, no matter how you look at it, is the heart of the quality management system. CAPA can be viewed as and is the merging of change control, continuous improvement, and complaint management.

What does the CAPA system do for the organization? CAPA not only indicates the organization's ability to respond to problems that arise but also to proactively anticipate and prevent subsequent problems from arising.



This webinar highlights the various regulations governing CAPAs, how…

The presentation will focus on FDA responses to failures in Change Management.

The presentation shall describe how FDA expects firms to establish change management, the sources of change management, the outcomes from change management, and timely outcomes. We will cover some suggestions and Do's and Dont's.

This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.

One of the cornerstones of the safety standards such as ISO 14971 is risk management. The principles relating to risk management set out by these standards keep getting updated from time to time. Because of this, it is imperative for organizations that come under the purview of the ISO standards to implement and maintain safety standards that comply with the requirements set out by them.

ISO 14971’s 2019 update will be explained in a lucid manner at a webinar that is being organized…

Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.

A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…

Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.

A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…

Corrective and Preventive Action (CAPA) is the foundation of a robust Quality Management System (QMS). Building a compliant, effective, and solid CAPA process into the QMS is the only way by which a company's QMS can guarantee safe and effective products.

A weak CAPA process invites disastrous consequences like complaints, recalls, 483s, and Warning Letters. It is a fact that CAPA is one of the most frequently cited reasons by the FDA for issuing 483’s and Warning Letters. Moreover, a…

This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits. Or else, the ambulance has to be called. All this has to done during what is called the Golden Hour: the most…

ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices.  This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies.  A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient.  The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the…