The FDA Quality and Regulatory Consultants (FDAQRC) website is fully owned and maintained by FDA Quality and Regulatory Consultants, LLC (“FDAQRC”, “We”, “Us”). FDAQRC is committed to protecting and respecting our clients, consultants and connections.
Please review our polices and contact us if you have any questions or concerns.
Privacy / Terms & Conditions
Data Protection Officer
Our President acts as our Data Protection Officer. The Data Protection Officer is responsible for assisting our personnel and subcontractors in ensuring that privacy policies and procedures are implemented and followed and may be contacted using the contact information in the “Contact Information” section below.
Data Collection and Processing
- We may collect and process data about your use of our website (“usage data”). The usage data may include your internet protocol IP address, geographical location, browser type and version, operating system, referral source, length of visit, page views and website navigation paths, as well as information about the timing, frequency and pattern of your service use. The source of the usage data is Google Analytics. This usage data may be processed for the purposes of analyzing the use of the website and services. The legal basis for this processing is monitoring and improving our website and services.
- We may collect and process your personal data (“account data”). The account data may contain standard, non-sensitive information including your name, e-mail address, employer, job title, company address, industry and phone number. The source of the account data is you or your employer and the account data may be collected when you submit an inquiry form on our website, subscribe to a newsletter or correspond with us by phone or e-mail.
The account data may be processed for the purposes of providing our services, ensuring the security of our website and services, maintaining back-ups of our databases and communicating with you. The legal basis for this processing is your consent or the performance of a contract between you and us or taking steps, at your request, to enter into such a contract.
You are not required to provide us with account data in order to access or use portions of our website, but you may be unable to access the entirety of the website (including without limitation portions we make available only to subscribers) and you will be unable to contact us or receive (or engage to receive) services.
- We do not collect or receive any Individually Identifiable Health information (any information that is a subset of health information, including demographic information collected from an individual that relates to the past, present or future physical or mental health condition of an individual and that identifies the individual; or with respect to which there is a reasonable basis to believe the information can be used to identify the individual) and is not considered a Covered Entity or Business Associate of such an Entity by regulatory definition. Should we come into possession of such information we shall ensure that it is de-identified (health information that is not considered individually identifiable because particular identifiers specified in the regulations are removed from the health information) and will otherwise treat and protect such information in accordance with applicable regulations. Further, we will treat Potentially Sensitive Personal Information (PSPI) of a personal nature (e.g., Financial Records, Bank Records, etc.) in a manner consistent with its sensitivity.
- Our website uses Google Analytics and HubSpot to collect usage data. This usage data may contain information about the website that you came from, the pages of our website which you visit, IP addresses, the type of browser you use and the times you access this website. This is statistical data about our users’ browsing actions and does not identify any individual.
- No collected usage data is linked to any Personally Identifiable Information. Our marketing system uses this data to provide you with a smooth, efficient and personalized experience while using our services.
When Google Analytics and HubSpot collect usage data, they are data processors. Both companies have data processing policies compliant with the EU General Data Protection Regulation (GDPR).
Data Disclosure and Storage
- We do not sell, rent or lease collected data to any third parties. As your data controller, we are responsible for your information and keep your data stored on secure cloud providers, including Microsoft 365, Mailchimp, Code Two and HubSpot, in accordance with applicable data protection laws.
- We may retain account data until such time that it is requested to be removed, in accordance with applicable international regulations and our policies.
- We may share your data for the purpose of conducting business and only when it is explicitly necessary to share your information to fulfill our obligations to you.
- Our main offices are located in the United States. If you live in another jurisdiction, your data may be transferred into the United States for storage and processing, in compliance with applicable law.
- We do not use any automated decision-making in the provision of any of our services.
Your Rights Over Your Personal Data We Hold
- You can reasonably request access to the personal data we hold on you, in a commonly used and machine-readable format (sometimes referred to as “data portability”), at any time, and we will provide that information free of charge within 28 days of your request at the latest. To make a request, contact us at the information below.
- You can request inaccurate or incomplete personal data held on you to be rectified or completed or for your personal data to be restricted or suppressed, and we will respond within 28 days of your request at the latest. To make a request, contact us at the information below.
- You have a right to be forgotten or for your personal data to be erased, and a right to withdraw your consent or otherwise object to our use of your personal data. You can ask us to erase your personal data at any time or withdraw our right or object to our use of your personal data by contacting us at the information below.
- If you request that your personal data be restricted, suppressed or erased, or you withdraw your consent or object to our use of your personal data, we may no longer be able to provide services to you. We will inform you of any such limitation when we respond to your request.
- If you live in a EU member state, you have a right to file a complaint regarding our use of your personal data with a local data protection authority. If you would like information about the local data protection authority in your jurisdiction, please contact us at the information below.
Commitment to our customers
Commitment to Customer Service:
Consulting Service is our high priority. Our mission is to bring a technical expertise to our Clients while providing high-quality deliverable in order for our Clients to succeed. We also seek to help our Consultants perform meaningful work that will make the most of their advanced skills. FDAQRC has two (2) customers Clients and Consultants.
Inspired by David A. Fields, we commit to:
- Being responsive: We will return phone calls, reply to emails and respond to requests quickly.
- Thinking beyond the proposal and kickoff: We’ll send reminders and proactively discuss changes.
- Being admirable and keeping on track: We exhibit limits and boundaries, which creates goodwill to actively manage the project utilizing a home-based resource.
- Managing and meeting expectations: We do this through a shared Communication framework.
- Understanding you and your way: Being technicians ourselves, we get it. We create customized solutions and deliverable.
- Revealing your blind spots: We take some time to think through what might be missing.
- Putting your needs and interests ahead of our own.
To measure our service performance and quality of commitment, FDAQRC has developed a robust feedback customer service program. There are seven (7) feedback surveys that act as tools completed by all Stakeholders to support our program. We are able to generate performance metrics from these data inputs. Outcomes of this program include thanking the customers for helping by providing candid comments making a difference, acknowledge and reward the employees and consultants who’ve contributed to success, publicized the good news, and opportunities to improve internal activities.
Customer service is what makes us successful.
Consultant Travel Reminders
As a consultant, you may be expected to travel on behalf of FDAQRC. Sometimes travelling for a project can be stressful and there are a lot of boxes to check. In order to make travelling for FDAQRC as seamless as possible, here are a few reminders when preparing to travel.
FDAQRC will always provide air or rail travel for consultants via Corporate Traveler. We will work with you to accommodate your travel preferences and required travel times for departure and arrival. This is not something that would need to be included on an expense report because FDAQRC pays Corporate Traveler directly.
On the other hand, FDAQRC does not pay for lodging directly. We work with Corporate Traveler to make arrangements and book a room for consultants; however, it is the consultant’s responsibility to pay for the room upon arrival. It is important to remember this so you can be prepared for the costs when you arrive. FDAQRC will reimburse the cost of lodging as part of a completed expense report. To receive full reimbursement, our accounting team will need to receive an original copy of the receipt from the hotel, etc. along with the expense report.
Consultants will be responsible for paying for food and other expenses while travelling for a project. With the proper receipts, these costs will all be reimbursed by FDAQRC. All costs should be outlined in an expense report with a copy of the original receipt attached. Consultants should also follow their Purchase Order regarding costs and reimbursements.
FDAQRC uses BigTime to track and submit expense reports. The consultant will be responsible for tracking all expenses and submitting them to BigTime. Our accounting team uses BigTime to track expenses and hours in order to properly bill the client and reimburse consultants. If there are questions about BigTime or expense reports, consultants can contact their project manager or the accounting team. Click here to read our article about common mistakes and pitfalls while submitting your expense report.
We understand that sometimes there are overages or other unexpected expenses when travelling or working on a project on our behalf. If there are any known overages, consultants should contact their project manager as soon as possible to approve these costs before booking to ensure they will be fully reimbursed.
The health of FDA Quality and Regulatory Consultants employees and consultants is our top priority. Because of this, we ask all employees and consultants to cooperate in taking steps to reduce the transmission of communicable diseases. We remind employees and consultants who are working outside of their home offices of the following:
- Stay home when you are sick
- Wash your hands frequently with warm, soapy water for at least 20 seconds
- Cover your mouth with tissues whenever you sneeze, and discard used tissues in the trash
- Avoid people who are sick with respiratory symptoms
- Clean frequently touched surfaces
Employees are encouraged to use telephone and video conferencing instead of face-to-face meetings as much as possible during this outbreak. If you need assistance with technology, IT support services are available on a case by case basis.
We ask clients to communicate with us if their schedules change due to the COVID-19 outbreak so we can continue to provide the best customer service to both our clients and our consultants during this critical time.If you have concerns or questions, we encourage you to communicate with your Project Manager with scheduling concerns.
It is extremely important employees and consultants do not expose others while they are experiencing respiratory symptoms such as fever, cough, shortness of breath, sore throat, runny or stuffy nose, body aches, headache, chills or fatigue. Currently, the United States Centers for Disease Control and Prevention recommends that employees remain at home until at least 24 hours after they are free of fever (100 degrees F or 37.8 degrees C) or signs of a fever without the use of fever-reducing medications. Many times, with the best of intentions, employees report to work even though they feel ill. We are asking employees and consultants to communicate with their manager if they are feeling ill and to exercise caution and stay home if they are experiencing respiratory symptoms.
FDAQRC will monitor the COVID-19 outbreak closely, following guidance from the World Health Organization, the UAE National Emergency Crisis and Disasters Management Authority, India’s national health agency, and the U.S. Centers for Disease Control and Prevention. By following these important precautions and by planning, we can help contain and prevent the spread of coronavirus.
State-By-State US Travel Restrictions – January 2021
By state resources