KIBW Concept - Kirsten Waever
Kirsten Waever

Kirsten Waever

Owner and founder of KIBW Concept.

KIBW Concept was founded in 2001 concentrating in GMP training and Audit activities. The company expanded in 2010 also to include activities such as CMC and Due Diligence, Quality Systems and QP duties.

Ms. Kirsten Waever has been Head of Quality Assurance at Affitech A/S (previously Pharmexa A/S) for 5 years. Ms. Waever joined Pharmexa in 2005, after having spent a career of more than 20 years at LEO Pharma where she hold a variety of technical and management positions of increasing responsibility. Among others, she holds positions in sterile/aseptic production and packaging, as well as in quality assurance, quality compliance, quality control and microbiology.

She has extensive practical experience in GMP (including cell banking and industrial process development and validation), GLP and GCP procedures as well as in the establishment and maintenance of all aspects related to state-of-the-art quality systems; the conduct of external audits (more than 160 audits) and self-inspections; validation; handling of change controls, deviations, complaints and product recalls in line with applicable regulatory requirements and legal regulations. This also to include review of CMC regulatory package and due diligence.

Ms. Waever has held several GMP courses since 1992 covering  basic GMP for finished medicinal products, Investigational Medicinal Products and Active Pharmaceutical Ingredients which includes QA issues like audit technique, quality systems, ICH guidelines and validation topics. Further, she has participated in 4 FDA inspections and more than 15 local authority inspections as team leader.

Ms. Waever received an MSc Pharm degree from Denmark's Pharmaceutical University in 1982 and became an "APIC Certified Auditor" in 2010 covering APIs manufactured by Synthesis/Cell Culture - Biotechnology/Fermentation. She has consistently updated her GMP knowledge through net working, GMP courses and audit activitie