Adam Fleming
Member since: Jul 14, 2017
Published articles: 87
The Prime Minister is set to meet with business leaders from the UK’s financial services industry as the government attempts to secure a Brexit deal that will include the sector. Theresa May will talk...
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration Maintaining their Quality Management System (QMS) processes in a state of...
Controlled Document System for a Life Sciences Manufacturing Plant - Principles of Lean Documents and Lean Configuration Maintaining their Quality Management System (QMS) processes in a state of...
The US economy’s appetite for ingesting food imports is phenomenal, to use a mild term. How else does one describe an economy that takes in $49 billion a year? Considering that the FDA is the sole...
Organizations need an efficient Incident Response Program if they have to respond with speed and agility to a cyber incident. While such a program should empower businesses to maintain continuous...
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities As suppliers and contractors work closely with pharmaceutical or biologic finished product manufacturers...
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities As suppliers and contractors work closely with pharmaceutical or biologic finished product manufacturers...
The criticality of validation to the Quality System Regulations and ISO 13485 can never be understated. Failure to validate attracts 483 observations from the FDA. Failure to validate has other...
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations The EU Medical Device Regulation (MDR) recently brought about major changes into its regulatory...
If there is one reason for which laboratories, utility operations, and production have to invest huge expenditures and effort on items such as labor for system sanitization and additional testing and...
The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine...
FDA Best Audit Behavior Practices - Do's and Don'ts Any regulated business, such as pharmaceuticals or medical devices, is expected to face an inspection by the FDA. The Food, Drug and Cosmetic Act...
cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become...
New import requirements are being brought into effect by the FDA and U.S. Customs and Border Protection. The commonality between these two programs, the FDA's import software screening program...
A few sciences are changing our lives in more ways than we could have imagined a few decades ago. Artificial Intelligence (AI) is at the forefront of these. Although a few decades old, it has received...
Author Bio
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.