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  • Guidance on Software and Device Changes and the 510(k)

    Guidance on Software and Device Changes and the 510(k)

    Drug Development Fremont (California) August 14, 2017 Free

    Overview: The first guidance document clarifies key terms and provides insight as to how a risk assessment can help medical device manufacturers to evaluate whether a new 510(k) is required. Why should you Attend: Anyone who is involved in software a...

  • NIST Cybersecurity Framework For Computer Systems Validation

    NIST Cybersecurity Framework For Computer Systems Validation

    Quality Control, Safety & Security Fremont (California) August 14, 2017 Free

    Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal informatio...

  • 483 Covers a Broad Gradation of Problems

    483 Covers a Broad Gradation of Problems

    Biomedical Sciences Fremont (California) August 14, 2017 Check with publisher

    Overview: How you respond to the 483 should provide the foundation for any future communication with the FDA about a particular inspection. Understanding how FDA organizes its evaluation of the 483 can facilitate the FDA’s review in your favor as it ...

  • How to Develop the Risk Management File - 2017

    How to Develop the Risk Management File - 2017

    Clinical Fremont (California) August 14, 2017 Check with publisher

    Overview: The single most important element of medical device risk management is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of y...

  • Analytical Instrument Qualification and Validation Processes - 2017

    Analytical Instrument Qualification and Validation Processes - 2017

    Medical - Health Fremont (California) August 14, 2017 Check with publisher

    Overview: In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that ar...

  • Medical Device Engineering Change Control - 2017

    Medical Device Engineering Change Control - 2017

    Medical Sciences Fremont (California) August 14, 2017 Check with publisher

    Overview: This webinar will describe a system, based on the regulations and practical experience that will allow for efficient control of the change process. It will be compliant but not cumbersome or overly time consuming. The difference between pre...

  • Batch Record Review and Product Release - 2017

    Batch Record Review and Product Release - 2017

    Drug Development Fremont (California) August 14, 2017 Free

    Overview: A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. Why should you Attend: ...

  • Cybersecurity and Computer Systems Validation - 2017

    Cybersecurity and Computer Systems Validation - 2017

    Computers - Software Fremont (California) August 14, 2017 Free

    Overview: Computer systems used in highly regulated companies include sensitive and valuable information. Some of this information includes valuable electronic submissions, clinical information, medical device design control records, legal informatio...

  • Compliance for Computer Systems Regulated by FDA - 2017

    Compliance for Computer Systems Regulated by FDA - 2017

    Chemical Methods Fremont (California) August 14, 2017 Free

    Overview: The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philo...

  • Laboratory Have an Instrument Calibration Program -2017

    Laboratory Have an Instrument Calibration Program -2017

    Chemical Methods Fremont (California) August 14, 2017 Free

    Overview: This web seminar builds on the terminology found in 21CFR160(b)(4) and introduces terminology and concepts not found in the regulation, but necessary for an effective calibration program, such as instrument classifications. Why should you A...

  • What are Standards for Medical Device Software -2017

    What are Standards for Medical Device Software -2017

    Medical Sciences Fremont (California) August 14, 2017 Check with publisher

    Overview: With various changes to standards and regulations, it is important to understand the criteria for compliance, this is your DIY guide to the changes in standards, specifically covering the IEC 62304 standard. Why should you Attend: Why do al...

  • GLP Comparison with GMP in Quality System -2017

    GLP Comparison with GMP in Quality System -2017

    Medical Sciences Fremont (California) August 14, 2017 Check with publisher

    Overview: Good Laboratory Practice (GLP) is a quality system which intend for non-clinical studies and was revised by several bodies. GLP is a unique quality system in the sense it is intend for non-routine processes and activities. Why should you At...

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