Safety Management and OSHA Compliance

Development of a safety program to save costs, delayed schedules and the human cost of injury or death.

Safety management guidelines and techniques for the engineering, construction, and scientific professions.

Documenting Software for FDA Submissions

The Agile methodology is an important tool for software project management.

All about biosimilars –from development to registration

Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured.

HIPAA compliance expectations from Small Healthcare Providers

If your small healthcare practice needs to understand how to put a HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive Two-day training course.

Change Control is at the core of GMP Compliance

The effectiveness of these items will determine the success of your change control program and help assure regulatory auditors that your equipment, utilities and systems remain in a state of control.

Quality by Design using Design of Experiments 2017

The ICH has offered further guidance and policies for explaining the ways by which the QbD approach should be integrated into the pharmaceutical Quality System

Writing and implementing effective SOP’s

writing and implementing effective SOP’s. This is because Standard Operating Procedures are to be designed keeping

Validation the complies with ICH guidelines

A clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures, and acceptance criteria in calibration limits is required from professionals in the field of statistical analysis. They also need to have a proper understanding of process and quality controls, as […]

Four years of the EU’s Cosmetics Product Regulation

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it […]