Building a goal oriented pathway into which proper design precedes development activities for various Analytical and Test Methods as a means for building Quality into the method right from the start is extremely crucial. This is emphasized by The American Chemical Society (ACS), and is the nucleus of pharmaceutical Quality by Design (QbD). So, how […]
Outsourcing is a common practice in the pharma and biological industries. Manufacturers of pharmaceutical and biological products outsource many of their manufacturing processes to contractors/suppliers. This arrangement bestows many benefits for both sides. However, lack of clarity about the terms of the contract can become a cause for contention when there is a disagreement or […]
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Any business organization that is involved in creating, receiving, transmitting and maintaining Protected Health Information (PHI) has to comply with the requirements set out in Health Insurance Portability and Accountability Act (HIPAA). Such businesses, called Business Associates, since they carry out these functions on behalf of what are called Covered Entities; are legally obliged to […]
GlobalCompliancePanel have been successfully organized the 2 days seminar in Philadelphia, PA from May 17th & 18th, 2018 by NetZealous LLC. The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled “Process Validation: General Principles and Practices” […]
The data generated by clinical trials serves as a critical raw material for clinical studies and the subsequent development of drugs or other medical products. This input, called clinical data, is very valuable in helping pharmaceutical, life sciences and medical device companies innovate and produce new products. This data is invaluable for companies that are […]
Getting the Root Cause Analysis (RCA) right is at the soul of the implementation of an effective Corrective and Preventive Action (CAPA) program.
Businesses that want to register and maintain combination products in the US and the EU face two markets that are as different from each other as chalk is from cheese.
Which GMPs Apply Since Most Phase I Drugs are Exempt from Full GMP Requirements, and What IND Data Requirements Are Necessary as a Result?
Imparting a full understanding of the HIPAA requirements, which will help entities safeguard PHI in a manner that meets the regulatory requirements, is the intent of a seminar from GlobalCompliancePanel, a globally trusted provider of professional trainings for all the areas of regulatory compliance. President and Founder of Colington Security Consulting, LLC, Jay Hodes, will be the Director of this two-day, in person seminar.