Pharmaceutical Opening Statement

Opening statement and my highlights of qualification

Yes, I have extensive experience in interpreting and providing advice on operating procedures, policies, and guidelines. I am a Quality and compliance professional within the pharmaceutical and research industry, with over 20 years of leadership experience within the US FDA, Health Canada (TPD), OECD GLP, and EMA regulated environments.

I have worked for generic pharmaceutical companies and contract research organizations, where activities ranged from research and development to the commercialization of products for worldwide market distribution. I am experienced in the areas of quality assurance, documentation management, supplier quality, controlled drug substances, and regulatory (GMP,

For example, as a Head of Quality Assurance, I have implemented the Standard Operating procedures related to physical security requirements outlined in Health Canada Controlled Drugs and Substances Act in order to possess the Controlled substances at current and previous organizations that I worked for. Policies and procedures were written in compliance to outlines the processes for accessing, recording and destroying of controlled substances. For example, controlled substances that are used as reference standard material (RSM) for bioanalytical purposes and have an approved regulatory test kit (TK) number are exempted from the Controlled Drugs and Substances Act. Controlled Drug is a drug containing any substance listed in the Schedule of Canada’s Controlled Drugs and Substances Act (CDSA). This includes narcotics, targeted drugs, and other sub-classifications of controlled drugs that are defined in related regulations. QPIC and/or A/QPIC are required to maintain records of all controlled substances that have been purchased, received, used/or

I have experience in the application of Good Manufacturing Practice (GMP) including food manufacturing industry. As a quality control specialist, I was responsible for monitoring, reviewing raw batch records, and auditing finished products both in drug and food industry (Nestle Canada). The onsite monitoring of quality checks of food products such as chocolate goods, packaging materials, cleaning records of equipment, labelling requirements became as part of Quality