Rising in one’s career through leadership management

Being a manager is an exercise in continuity. One does not become a manager and stop there. It is important to be, than to become managers. This means that management is a journey, not a destination. Because of this, continuous improvement is needed into this discipline from time to time. Leadership management is needed to […]

Applied Statistics for FDA Process Validation

The pharmaceutical industry considers Applied Statistics for FDA Process Validation to be of very high importance. In 2011, the FDA set out this guidance for the industry. as part of this guidance, called “Process Validation: General Principles and Practices”, which sets the framework for Process Validation in the pharmaceutical industry, any organization in the pharmaceutical […]

GlobalCompliancePanel announces Seasonal offers for Professionals with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a […]

Management systems should be built on expansiveness and versatility

Management systems should be built on expansiveness and versatility. Only such a system delivers results for an organization. First of all, let us get a basic understanding of a management system: It is a system that helps smoothens and streamlines an organization functioning, enabling it to go on without hiccups. The purpose of a management […]

GlobalCompliancePanel Professional Training and Development Courses with Flat 50% OFF on all Seminars

Do celebrations need a cause and a reason? Yes, and GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, is having a solid cause and reason for doing so. It is celebrating the many years of its relationship with its customers spread all over the world by offering its trainings at a […]

Unravelling the DHF, Technical File and Design Dossier

Design History File (DHF), Technical File and Design Dossier are important regulatory documents for a medical device. Design Control and Design History File are regulatory documents for medical devices in the FDA, while the Technical File and Design Dossier serve the same purpose for the EU’s regulatory body, the MDD. The Design History File The […]

How to build a complete Safety, Health & Environment Management System through Standards & Practices 2017

    Course “How to build a complete Safety, Health & Environment Management System through Standards & Practices” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Overview: A management system, by definition, is a process by which a function or functions are carried out in an organization […]

Standard Operating Procedures are crucial documents in the regulatory industry

  Standard Operating Procedures (SOPs) are very important documents that can make or break an organization in the regulatory industry. In simple terms, a Standard Operating Procedure, as suggested in its nomenclature, is a description of a specific operational procedure in which all the activities necessary to complete tasks that conform to established best practices, […]

Management for Medical Device Industry

  A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent […]

Dealing with medical device reporting and recalls

Medical device reporting and recalls have enormous benefits for the medical device company and the public if implemented properly. They can prevent use of defective devices and can be an important inoculation against stringent FDA actions. Medical device reporting and recalls are a major FDA activity. Medical device companies have clear instructions on how to […]