- Nov 10, 2003
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Do you have any experience in the pharmaceutical industry? No
If not, why have you chosen to apply to this position? Because I have the education, I am very good in math/science, and I worked in a laboratory environment before.
Do you have any knowledge of the clinical trial process, and its purpose? Yes, in order for a drug to be used, it has to follow these steps:
drug development in lab, test in lab, test in animals, test in human volunteers, test again, phase II test, phase III test, FDA approval/rejection.
Do you have any experience in clinical trials? I attend the process selection for clinical trial at ABC in February 2006
Do you have any knowledge of medical terminology? Please explain. Yes, I studied biology in HS and college. I am always interested in the medical/pharmaceutical field.
Do you have any knowledge of FDA regulations? FDA Federal Food and Drug Administration regulates food and drug to be consumed by consumer in the US. Any new drugs must be tested extensively before it can be bought to the market.
TPD regulations? Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations
Do you have any knowledge of ICH GCP? GLP? GMP?
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials
The primary objective of the OECD Principles of Good Laboratory Practice (GLP) is to ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations in the framework of harmonizing testing procedures for the Mutual Acceptance of Data (MAD).
Good Manufacturing Practice/Quality Systems (GMP) Compliance and performance are the goals of every food, drug, cosmetic, blood, and medical device manufacturer. But they don't just happen. They are achieved when FDA's Good Manufacturing Practice Regulation becomes a lifestyle shared by everyone in the organization.
What formal training have you received in the specified position? I have a BS in
Quantitative Management, minor in Computer Science, and a MBA. I also worked in QC in a laboratory.
If you have answered 'no' to two or more of the questions above, would you be willing to go through training? Yes, I would.
Are you a fast learner and can you manage well in a very intensive training environment? I am a fast learner and I work well under pressure. I worked full time at XYZ and went to grad school part time for my MBA degree. It showed that I could manage time well and knew how to set priority.
If not, why have you chosen to apply to this position? Because I have the education, I am very good in math/science, and I worked in a laboratory environment before.
Do you have any knowledge of the clinical trial process, and its purpose? Yes, in order for a drug to be used, it has to follow these steps:
drug development in lab, test in lab, test in animals, test in human volunteers, test again, phase II test, phase III test, FDA approval/rejection.
Do you have any experience in clinical trials? I attend the process selection for clinical trial at ABC in February 2006
Do you have any knowledge of medical terminology? Please explain. Yes, I studied biology in HS and college. I am always interested in the medical/pharmaceutical field.
Do you have any knowledge of FDA regulations? FDA Federal Food and Drug Administration regulates food and drug to be consumed by consumer in the US. Any new drugs must be tested extensively before it can be bought to the market.
TPD regulations? Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations
Do you have any knowledge of ICH GCP? GLP? GMP?
The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration
Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials
The primary objective of the OECD Principles of Good Laboratory Practice (GLP) is to ensure the generation of high quality and reliable test data related to the safety of industrial chemical substances and preparations in the framework of harmonizing testing procedures for the Mutual Acceptance of Data (MAD).
Good Manufacturing Practice/Quality Systems (GMP) Compliance and performance are the goals of every food, drug, cosmetic, blood, and medical device manufacturer. But they don't just happen. They are achieved when FDA's Good Manufacturing Practice Regulation becomes a lifestyle shared by everyone in the organization.
What formal training have you received in the specified position? I have a BS in
Quantitative Management, minor in Computer Science, and a MBA. I also worked in QC in a laboratory.
If you have answered 'no' to two or more of the questions above, would you be willing to go through training? Yes, I would.
Are you a fast learner and can you manage well in a very intensive training environment? I am a fast learner and I work well under pressure. I worked full time at XYZ and went to grad school part time for my MBA degree. It showed that I could manage time well and knew how to set priority.
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