Pierangela has been working in Quality Assurance since 1996 in a variety of GCP clinical trials spanning all phases (1 to 4) and therapeutic areas (autoimmune, cardiovascular, endocrine, gastrointestinal, infectious, mental health, neurology, oncology, rare diseases and respiratory) throughout Europe, Africa, Asia and the Americas.

She is the founder and principal consultant of It’sQA^TM, the ISO 9001 and no 1 provider of independent and experienced Quality Assurance (QA) services for the health care and information technology sectors involved in drug development.

Always at the forefront for improving the quality of clinical trials by applying research to Quality Assurance since 2005, It’sQA^TM have revolutionized QA for the pharma and biotech sectors, with their innovative virtual consultancy model of harnessing localized expertise from around the world working together under the same It’sQA^TM umbrella. Together they have provided thousands of international clinical GCP audits of unmatched quality, including remote audits during the travel restrictions imposed by COVID.  

In addition for conducting audits, Pierangela has worked with biotechnology, pharmaceutical, software development and medical device companies, setting up and managing their inspection-ready QMS, writing SOPs, CAPA follow-up, and other QA functions. Pierangela is fluent in Italian & English and understands Spanish.

Availability for Work

Worldwide

Areas of Expertise

Auditing, Good Clinical Practice (GCP), Good Clinical Laboratory Practice (GCLP), Good Distribution Practice (GDP), Pharmacovigilance (GPvP), Quality Management Systems (QMS), Standard Operating Procedures (SOPs), Inspection Preparation, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Quality Risk Management (QRM)

Contact Details

Pierangela Sedda

Email: enquiries@itsqa.com

Telephone: +442031372977 or +447946354166

Website: http://www.itsqa.com

 

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