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,
…show more content…
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 …show more content…
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
Nt1310 Unit 9 Final Paper
773 Words | 4 PagesLarge farms, processing facilities, and factories are used by the industry with a variety of levels of security. There are often sanitation processes, good manufacturing processes, and hazard identification and control systems in place at processing facilities and factories. Even with these systems and processes in place, the overall facility or a single batch remain vulnerable. The highest risk comes from the employees either intentionally or unintentionally contaminating a batch of food. Testing is supposed to ensure the food is within specific allowances for contaminates, but the laboratory confirmation takes time that perishable items may not have to wait.
Letter To Controlled Substance Inspector
89 Words | 1 PagesThis letter is in response to the newly selected Administrative Officer, Glenn Butorac and his additional duty of “Controlled Substance Inspector”, which has carried over from the Primay Care Service. As a newly appointed Administrative Officer, he is not only my front line administrator, he is required several hours of continuous training and acclamation. For thesed reasons the PM&RS Service is respectfully requesting that he be removed from this duty. Thank you for your time and consideration, and please feel free to contact me with any questions or concerns.
Lethal Injection Drug Shortage Summary
607 Words | 3 PagesIn the article “Botched Execution Shows Perils of Lethal Injection Drug Shortage” discusses that the pharmaceuticals being used in today’s death-row executions are not being supplied to prisons. Drug manufactures are no longer supplying the lethal drugs, stating the drugs are being used against the company’s wishes. Furthermore, correctional centers are buying drugs illegally or trading drugs with other states in order to continue the lethal injection to death-row inmates. The author states that correctional facilities have been taken to court and are refusing to disclose information as to what compounds they are using on death-row inmates.
Sterile Processing Technician Proposal
152 Words | 1 PagesIn request for proposal to be qualified as a Sterile Processing Technician Program. My career objective has always been to work in a setting where I find propose in caring for others. To be a member of the healthcare world has always been a long time goal. While searching for employment I came across the program in which I believe this will be a great opportunity working toward my goal. My previous employment obligations were working with individuals in a direct support setting with DDS Residential Group Homes.
State Office Cover Letter
991 Words | 4 PagesI have filled in for Central Registry and Non-IV-D several times during the years. I have also served on the functional design team for CAFÉ. I continue to do each of these while serving as contract monitor for eleven district attorney’s offices. In addition to the experience gained in the policy unit, I have also served as a Store Manager for Radio Shack #01-8238.
The Pros And Cons Of The Pharmaceutical Industry
1631 Words | 7 PagesNowadays it seems like legal drugs are more expensive than illegal ones. This dilemma occurs because the pharmaceutical industry affects the economy significantly. Although the United States is a mixed market economy, there are instances where the economy seems like a free market economy. A free market economy allows companies to determine the prices of goods free from government intervention. The pharmaceutical industry, despite several regulations set by the food and drug administration, is a free market economy.
Senior Nurse Personal Statement
1025 Words | 5 PagesI am an experienced hardworking, reliable and motivated Senior Nurse. I lead by example and thrive on challenges. I am able to demonstrate excellent communication skills and this is evident when working well within the multi-disciplinary team (MDT). I have worked in Alder Hey children’s Hospital for fourteen years, working initially within the Oncology unit for eight years were I acquired a vast knowledge of sepsis.
A Brief Note On Recognizing And Understanding Medication Safety
1259 Words | 6 PagesSecondly, the way the resident receives his medications should consist of the CM stating what each of the medications are so the resident is aware what he is taking. By implementing this, the CM can do the final check of administering the medications. If the medications themselves could be barcoded and scanned in before popping the medication in the medication cup, this would help the CM double check the five rights as well. A bar-code electronic medical administration record (eMAR) technology associates several technologies into the medication administration process to provide the correct medication, dose, time, route, and patient. This technology will provide an additional check and implement safety (Poon et al., 2010).
Rhetorical Analysis Of How Big Pharma Is Trying To Improve Its Image
487 Words | 2 PagesIn the online article, How Big Pharma is Trying to Improve its Image, Jim Hightower establishes his argument that the PhRMA is merely after money by using advertising and lobbying. He supports his claim by using sarcasm to make his audience feel slightly ignorant and intense diction that also possesses a sarcastic underlying tone to persuade his audience of the PhRMA’s inability to be honest and fair. Afterwards, Hightower provides his audience with quotes from a CEO that further add to his credibility. Also, the text is structured in a specific order to slowly build up the readers anger.
Medication Administration Reflection
750 Words | 3 PagesReflection on Medication Administration Description (Competency 3j) I have looked over my moral development regarding medicine administration and have noticed there is the need for improved and has been agreed with my mentor to write a piece of reflection to identify areas of concern Feelings One of the major concern is the pace of dispensing and the time spent used to open charts and allocate them is one of my weakness. Although I am learner I need to back up the pace of dispensing so that patient doesn 't feel my skills is dull or boring and waste of time. I Had developed that feeling of being extra careful to avoid drug error and that makes me feel slightly nervous more also being under the influence of supervision as well. Evaluation
Essay On Medication Errors In Nursing
1497 Words | 6 PagesThese competencies include quality improvement, safety, informatics, teamwork and collaboration, evidence-based practice, and patient-centered care (Cronenwett et al., 2007). Each competency has its own knowledge, skills, and attitudes that when applied to medication administration, help warrant the best results. In order to
Tafe Education Case Study
1045 Words | 5 PagesPolicies and procedures concerning drugs intake or acquisition are dissimilar for countries. These policies change on a consistent base. The Medicinal tablets can be classified as drugs, this may lead one to jail because a listed amount of the usage of drugs may be safe today but the next may not. Every Educational property should have strict rules and handling commitment when they come into contact with a student with drug substances, a maximum of two warnings student who constantly disobey should be permanently removed of property for a semester, and also notify police involving the caught of drug
Essay On The Death Penalty Under Section 31A
1460 Words | 6 PagesThe first conviction, under Section 31A, must be for offences under Sections 19, 24, or 27A or for offences involving commercial quantity of NDPS and the second conviction must be for offences involving narcotic drugs or psychotropic substances of the quantity as specified in the table in Section 31A(1)(a). The table specifies
Business Analyst Personal Statement
203 Words | 1 PagesI am a business Analyst carrying over 5 experience in Public Safety, Mobile Telecommunications, Green Energy and Telecom IT domains I graduated from Information Systems Business Analyst Program from George Brown College with Honours. I have worked in waterfall, iterative and Agile methodology. I have a strong ability to communicate well with the technical staff, business and IT management while adapting well to the technological changes. I have worked as a Project Manager for center infrastructure projects, mobile commerce and efficiency building programs participating for stages of the software-development life-cycle from requirements gathering, to design, development, testing and launching. Applications.
Porter's Five Forces Model Of Biscuits
1832 Words | 8 Pages• In China, government regulation and policies regarding food products are very strict due to various food safety scandals in recent years. All biscuit manufacturers have to reach the state standard requirements for quality, packaging etc. (IBISWorld, 2010). In order to meet the tightened regulatory requirements on food quality and environment protection, this would require huge investment in stringent quality and hygiene control measures for new entrants (Euromonitor, 2014). • Existing competitors that have achieved economies of scale in production has an advantage over new entrants in terms of the burdening of overall expenditures
More about Pharmaceutical Opening Statement
Nt1310 Unit 9 Final Paper
773 Words | 4 PagesLetter To Controlled Substance Inspector
89 Words | 1 PagesLethal Injection Drug Shortage Summary
607 Words | 3 PagesSterile Processing Technician Proposal
152 Words | 1 PagesState Office Cover Letter
991 Words | 4 PagesThe Pros And Cons Of The Pharmaceutical Industry
1631 Words | 7 PagesSenior Nurse Personal Statement
1025 Words | 5 PagesA Brief Note On Recognizing And Understanding Medication Safety
1259 Words | 6 PagesRhetorical Analysis Of How Big Pharma Is Trying To Improve Its Image
487 Words | 2 PagesMedication Administration Reflection
750 Words | 3 PagesEssay On Medication Errors In Nursing
1497 Words | 6 PagesTafe Education Case Study
1045 Words | 5 PagesEssay On The Death Penalty Under Section 31A
1460 Words | 6 PagesBusiness Analyst Personal Statement
203 Words | 1 PagesPorter's Five Forces Model Of Biscuits
1832 Words | 8 Pages