Global Supply Chain Regulatory Compliance

Global supply chain regulatory compliance has become more important than ever before because of the confluence of a number of factors. As globalization becomes inevitable and inescapable, the global supply chain is one of the core arenas in which it plays out. The outgrowth brought about by globalization, namely outsourcing, has further increased the need […]

Understanding the infinite area of medical device compliance

With a seemingly unlimited number of products coming under the broad umbrella of medical devices; it is but natural that regulations for these products are equally expansive. This makes medical devices compliance an extremely enormous and broad topic. With the FDA being the sole regulator for this very vast area; it comes up with regulations, […]

Effective legal writing skills are essential for FDA submissions

professionals in the pharmaceutical and medical device companies clearly understand and effectively employ legal writing techniques to frame persuasive argument when negotiating with FDA

Development of technical training in the life sciences

Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers.

Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training. Training and development is a great tool for helping a professional or a lay […]

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 […]

Regulatory Filing Requirements for medical devices in Japan

  Japan is the world’s third largest market for medical devices, after the US and Europe. Ironically, many of the world’s medical device manufacturers find language barriers for communicating with Japanese regulatory authorities a greater barrier than passing through the regulatory maze! The regulatory filing requirements for medical devices in Japan are relatively less complex […]

Adherence to GMP is absolutely essential for Quality Control and Contract Laboratories

It is absolutely essential for contract laboratories to maintain the required standards of Quality Control because of the risk their process involves: After testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. This fact is the primary reason for which regulatory agencies such as the FDA, […]

A complete understanding of the payroll law

Those who are responsible for payroll or employer tax withholding compliance or have just been hired or promoted into the payroll department would have discovered during their indoctrination just how important this role is to the success of the organization. Their learning is a continuous process that goes on and on. Employees in this position […]

Globalcompliancepanel Successfully Completed Seminar in Los Angeles -New FDA FSMA Rules

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods