Independent Consultant
CurrentWorking with clients in the pharmaceutical, medical device, biologic, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA and EMEA regulations by:·Conducting assessments of client studies, procedures, and programs to determine compliance.·Assisting with development and implementation of quality systems and validation programs.·Developing and implementing corrective action plans to address deficiencies. ·Presenting GMP/QSR training.·Developing quality policies and procedures as related to validationRepresentative Clients:* Comet Group* Merz* Novartis* Ethicon* Sandoz* Genentech* Merck Serono* Abott* QIAGEN* Gerresheimer Wilden* Aptilon* CSL Behring* Medtronic* Gambro Renal Products* Cordis J&J* Eli Lilly* Bristol Myers Squibb* Phillip Morris* Innovex