Conferences - Calls for Papers

Listings
  • FDA's Medical Device Software Regulation Strategy

    FDA's Medical Device Software Regulation Strategy

    Medical Sciences san Jose (california) May 15, 2021 Check with publisher

    The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjun...

  • Project Management for FDA-Regulated Companies

    Project Management for FDA-Regulated Companies

    Medical Sciences Fremont (California) April 29, 2021 Check with publisher

    Overview: This webinar is not a project management certification course. It is designed to provide the non-project manager with the tools / techniques necessary to assist in achieving a result or deliverable to achieve that end, and document the acti...

  • Design History Files (DHF), Device Master Records (DMR)

    Design History Files (DHF), Device Master Records (DMR)

    Medical Sciences Fremont (California) April 29, 2021 Check with publisher

    Overview: It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be...

  • 21 CFR Part 11 - Compliance for Electronic Records and Signatures

    21 CFR Part 11 - Compliance for Electronic Records and Signatures

    Medical Sciences Fremont (California) April 29, 2021 Check with publisher

    Overview: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic recor...

  • Best Practices in Preparation for an FDA Computer System Audit

    Best Practices in Preparation for an FDA Computer System Audit

    Medical Sciences Fremont (California) April 29, 2021 Check with publisher

    Overview: As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into ...

  • Computer System Validation (CSV) and Software Testin

    Computer System Validation (CSV) and Software Testin

    Medical Sciences Fremont (California) April 29, 2021 Check with publisher

    Overview: Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expe...

  • Medical Device Single Audit Program [MDSAP] Implementation

    Medical Device Single Audit Program [MDSAP] Implementation

    Medical Sciences san Jose (california) April 20, 2021 Check with publisher

    Global Medical Device Regulations continue to evolve, as devices become more diverse and sophisticated. Understanding the regulations and requirements in your targeted markets will expedite speed-to-market of innovative products and assist patients n...

  • Design History Files and Technical Files/Design Dossiers

    Design History Files and Technical Files/Design Dossiers

    Medical Sciences san Jose (california) April 20, 2021 Check with publisher

    Global companies must meet different product design documentation for the U.S. and the European Union / Common Market. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is...

  • Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic

    Navigating the Medical Device Post-Market Maze and Challenges during COVID-19 Pandemic

    Medical Sciences san Jose (california) April 17, 2021 Check with publisher

    Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas. By attending thi...

  • Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

    Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

    Medical Sciences san Jose (california) April 17, 2021 Check with publisher

    In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”....

  • Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments

    Is My Nanotechnology Safe? Approaches For NanoEHS Risk Assessments

    Life Sciences san Jose (california) April 17, 2021 Check with publisher

    The FDA is still treating nanomaterials on a case by case basis. How can you determine if the nanotechnology you are considering is safe? FDA applications require proof of safety, as does public perception in an environment where using nanomaterials ...

  • 6-Hour Virtual Seminar on Master Class for the HIPAA Officer

    6-Hour Virtual Seminar on Master Class for the HIPAA Officer

    Medical Sciences Fremont (California) April 16, 2021 Check with publisher

    The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, such as Individual Rights and Uses & Disclosures, and recent and expected changes to HIPAA and other rules such a...