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

Globalcompliancepanel Successfully Completed Seminar in Philadelphia-Design of Experiments and Statistical Process

Design of Experiments and Statistical Process Control for Process Development and Validation

Identifying and managing key risks is the primary purpose of HR auditing

Human resources audit should qualify as the most important of all audits of an organization. This is because HR auditing is directly related to employees. This resource, the organization’s human capital, is the organization’s most important resource. It is through an HR audit that an organization evaluates this resource’s strengths and weaknesses. HR audits help […]

An understanding of HIPAA upcoming changes for 2016

Professionals at various levels of the healthcare industry need to have a grasp of the HIPAA Security/Privacy Rule and the way it relates to their practice or business. A two-day, in person, live seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will offer this very important understanding. […]

Getting Design of Experiments and Statistical Process Control right for Process Development and Validation

Procedures must be used in the application of DOE and SPC to the development, design and monitoring of manufacturing and testing processes. Why this needs to be done is because the FDA has, in a recent guidance document on Process Validation, assigned the responsibility for reviewing and interpreting DOE and SPC studies to the Quality […]

Getting design controls right is absolutely essential for medical device companies

Design Controls are absolutely essential for ensuring the safe and effective production of medical devices. The FDA too considers design Controls a critical process. Yet, design controls are among the most frequently cited areas for 483 and Warning Letter observations from the FDA. Although intrinsic quality, safety, and effectiveness of a device are known to […]

Extracting Information from Geochemical Data

Going beyond just asking the laboratory for geochemical extracting information of a gold test by sampling every meter of the drill core of a trench and using multielement analysis is an approach strongly recommended by most mining specialists. There exist other methods of geochemical data analysis techniques and obtaining geochemical extracting information, but these are […]

Ways of conducting a hassle-free internal and supplier audit for medical devices

Carrying out efficient and effective internal and supplier audits that meet all the requirements of external auditors is a must for medical device manufacturers. These audits should not only serve this purpose; they should also add value to the medical device organization. Part of both ISO 13485 and QMS Internal audits are required as part […]