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Recent Fda Compliance Qsrs Gxps Fda 483s Inquiries

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Fda

Looking for an fda consultant to establish a complete qsr program and process validation for a new business. Atlanta based a must.

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    Bob |Principal Consultant

    Good Day, My name is Bob Mehta and I have over 23 years of experience with managing and implementati...

    9 Minutes Later
  2. Profile Picture

    Andrea |Principal Consultant

    I am in California, but willing to be onsite in Atlanta for a project....

    52 Minutes Later
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    Glenn |VP Lab Ops, QA, RA, R&D

    This sounds like a great project and it is right up mu alley. I have significant successful experie...

    1 Hour Later
+13 Other Responses
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Fda Compliance

General overview listing of 483s for pharmaceutical manufacturers. I am researching the most inspected firms and the most observed gmp capa and quality system violations.

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    Bob |Principal Consultant

    Good Day, My name is Bob Mehta and I would be happy to help you with this project. It is a bit uncl...

    1.3 Hours Later
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    Patrick |COO

    I have expertise in auditing both ***** *****ical research sites for GCP complianc...

    1.2 Days Later
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    James |Independent Consultant

    Is this simply a ***** culling and parsing 483s from the FDA website?...

    2.2 Days Later
+6 Other Responses
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Fda 510k

We are a small medical device company. I have a fda cleared device and i want to add an indication for which no predicate exists. Fda recommended de novo 510(k). I have engaged hogan lovells to manage this submission but i need someone to be our arms, legs, and mind to prepare for pre-sub fda meeting and assist in submission creation. I need a hands-on doer to do real work, not just someone to tell me what to do. This is an exciting new product that is making a difference in lives. It is ce marked and approved in many countries. We are based in gaithersburg maryland just north of washington, dc.

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    Fda Compliance

    Looking for a former fda compliance expert in drugs specializing in data integrity and quality metrics. This engagement is for october 2016

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      483 And Warning Letter Remediation

      I'm looking for a medical device consultant that has expertise in working directly with the fda and/or remediation of 483's, warning letters, and consent decree situations. Onsite consulting will be required for a few days a month and up to 2 weeks a month.

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        Soio |Project Head

        I am an independent consultant. I can support you...

        1.4 Hours Later
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        Mercedes |Principal Consultant

        I am a consultant with over 30 years of experience in the medical device industry, including helping...

        2.4 Hours Later
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        Mary |President, Microbiology Network Inc.

        I would be interested in talking about this consultation. I have experience in this area and lead a...

        2.5 Hours Later
      +13 Other Responses
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      Medical Device Quality Assurance

      We are seeking a motivated individual to fill the position of quality assurance manager. The successful candidate will be highly self-directed with a demonstrated ability to work effectively in medical device product development and manufacturing environment. Will have experience in managing the company’s quality management system in compliance with fda 21 cfr part 820 qsr/gmp and iso 13485:2003. This is an outstanding opportunity to work within a fast growing company – with career growth potential. Duties and responsibilities: oversee and manage the quality system to assure compliance with national and international regulations required to develop, manufacture and provide highest quality services. Ensure that the company’s quality system is maintained and effective and ready for internal /external audits. Author, review and approve quality management system documents. Keep management appraised of product and field conditions through management review meetings, quality metrics and quality meetings, complaint feedback and post market surveillance information. Provide adequate internal audits, coupled with corrective actions to correct deficiencies found. Ensure product design quality through use of risk analysis, and qualification & validation activities. Will also act as document control coordinator to facilitate engineering change orders through the various epdm approval work flows. Education and experience required: bachelor’s degree (sciences) or extensive experience in a medical device development and manufacturing environment is preferable. 7+ years direct quality assurance/quality system experience in a medical device manufacturing environment 5+ years in a managerial role knowledge in the most current fda qsr/gmp and iso 13485 requirements. Asq certified auditor (i.E. Cqa) or certified iso 13485 lead auditor is preferred. Proficient in ms suites including powerpoint and visio hands on knowledge of compliance software program is a plus. Hands-on experience managing capas’, non-conforming product control program, supplier management/audits, internal and external audits, calibration program, complaints and iso 13485 management reviews. Good understanding of root cause analysis, risk analysis (iso 14971), quality management tools, and other international standards applicable to active medical device. Writing skill is paramount – must be able to write clear, concise, well –structured procedures and reports. We offer: competitive pay, paid holidays, paid vacations, medical insurance, life insurance, supplemental insurance including: short term and long term disability, accident insurance and hospital confinement indemnity insurance, 401k plan w/matching funds.

        +undefined Other Responses
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        Ce And Fda Approval

        New medical device company seeking regulatory medical device expert for ce and fda approval process. Prefer regulatory experience with extracorporeal devices including dialysis and apheresis filter technologies.

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          Mercedes |Principal Consultant

          I have over 30 years of experience in medical devices, a good portion of that with hemodialysis mach...

          12.8 Hours Later
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          Denise |

          Happy to help you out. Expert in CE mark and FDA submissions and approvals. Specialize in medical de...

          12.8 Hours Later
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          Denise |Zintro Expert

          Our company specializes in medtech *****tegy in the US and Europe. Excellent track record ...

          12.9 Hours Later
        +35 Other Responses
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        Fda Cmc Regulatory

        I am looking for a consultant with expertise regarding the qa process for fda cmc regulatory approval. Ideally, the consultant would be familiar with oral agents and elixirs.

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          Tai Wei |Sr. Director of Drug Development Technol

          I believe I should be able to help you with your query. I have been responsible for CMC in all our ...

          1 Hour Later
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          Plamena |Principal Consultant

          Hello - our consultancy can definitely assist you with your project; I have 10 years of RA with a fo...

          1 Hour Later
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          Nicholas |Director R&D

          I am a *****rance consultant and worked in the pharma area for over 30 years. The last te...

          1.1 Hours Later
        +24 Other Responses
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        Gxp

        We are a renowned boston venture capital firm looking for a gxp expert for compliance and auditing consulting for one of our portfolio companies selling software into pharma.

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          Les |Principal

          I can certainly assist you with your project. I have more than 40 years in the *****st...

          14 Minutes Later
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          Timothy |Principal

          I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

          16 Minutes Later
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          Scott |Sr. Technical Services Project Engineer

          I have over 19 years of experience in the Pharmaceutical industry leading project in R&D, Quality As...

          20 Minutes Later
        +26 Other Responses
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        Quality Management System

        Our client has a quality assurance & regulatory compliance manager position in mahwah, new jersey description: the manager, quality assurance & regulatory compliance will ensure overall quality management system (qms) compliance with applicable regulatory and statutory requirements. The successful candidate will manage the manufacturing site’s internal and external audit functions and will coordinate activities of third party audits /visits. In addition, the manager, quality assurance & regulatory compliance will be responsible for leading and managing a group of quality professionals to ensure a high level of quality management system and regulatory compliance in the plant. This position will be responsible for quality management system improvement, procedure development, and qms implementation. The manager will coordinate management review, capa, ncrb, complaints, product field actions, and related document control functions. Detailed responsibilities of the manager, quality assurance & regulatory compliance include, but are not limited to the following: *ensure overall qms system compliance with applicable regulatory and statutory requirements. *perform internal quality assurance audits to 21cfr 820, iso 9001:2000, iso 13485:2003, 93/42/eec and other applicable standards to ensure corporate and regulatory compliance *develop and conduct effective training programs on related qa topics. *conduct and support benchmarking activities. *identify areas of opportunity and support continual improvement of the quality management system identify, develop, and report qms metrics. *manage internal audits, capa system, complaint handling (investigation/resolution), document control. Requirements: a bachelor's degree in a scientific or other relevant field is required. A master's degree or equivalent additional coursework is desirable. Internal or lead auditor certification (cqa) is preferred. A minimum of 5 years of experience managing a team is also required. 3 years of experience in a quality role in the medical device industry is also desired. Ideal candidates should also possess the following skills/experiences: applied understanding of cgmps, iso 9001, iso 13485, and fda qsr. *demonstrated ability to effectively lead cross-functional/cross-plant project teams using relevant project management tools such as ms project. *demonstrated experience developing quality management systems, designing and developing training programs/courses. Experience with lean and six sigma methodology and tools. *demonstrated auditing experience in medical device or other regulated manufacturing environment (biotech, pharma, military, aerospace, automotive).

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          Mark |President

          Please consider AlvaMed if your client requires contract support in the short-term before they are a...

          1.4 Days Later
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          Erik |Manager

          This sounds interesting. It's a pitty that I can't meet up in person for a chat, since I am seeking ...

          2 Days Later
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          Andrea |Principal Consultant

          Hello, I have 18 years of experience in medical device Quality Systems and *****irs. Wou...

          3.5 Days Later
        +5 Other Responses
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        Fda Quality Metrics

        Hi, i'm a conference producer based in mumbai. I'm working on the 3rd annual data integrity, reliability and quality metrics workshop scheduled from october 18th-19th, mumbai and 20th-21st october, hyderabad. I'm working with former fda experts for this project. I was looking out for a former fda expert who could cover on quality metrics

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          Fda Filing

          We are looking for experts on fda filing process (oral solid dose, medical devices, parenteral packaging) for packaging & devices. Our key areas of expertise requirement are as below: 1. In case of supplier location changes or production contingencies, what is the process for fda filing for approval? 2. How do pharma companies file with fda for same packaging sourced from different manufacturing locations of a single supplier?

            +undefined Other Responses
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