Medical Sciences

Listings
  • Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

    Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

    Medical Sciences san Jose (california) November 28, 2020 Check with publisher

    The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. This new upcoming regulation is also stronger connected to the EN ISO 13485:2016. The understanding of this changes and how to implement last minut...

  • Medical Devices

    Medical Devices

    Medical Sciences san Jose (california) November 28, 2020 Check with publisher

    This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

  • Physician Employment Agreements: Items to Consider

    Physician Employment Agreements: Items to Consider

    Medical Sciences Fremont (California) November 20, 2020 Check with publisher

    Overview: We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understa...

  • Physician Compensation Update: What Providers Need to Know

    Physician Compensation Update: What Providers Need to Know

    Medical Sciences Fremont (California) November 20, 2020 Check with publisher

    Overview: In this session Mr. Wolfe will provide an overview of key developments in physician compensation in 2020. Why you should Attend: It has been a whirlwind year for physician compensation in the U.S. Since last year, the government has issued ...

  • HIPAA HITECH Changes 2021 - What's New?

    HIPAA HITECH Changes 2021 - What's New?

    Medical Sciences Fremont (California) November 20, 2020 Check with publisher

    Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves ...

  • Hazardous Material Release Reporting Requirements

    Hazardous Material Release Reporting Requirements

    Medical Sciences Fremont (California) November 17, 2020 Check with publisher

    Overview: Hazardous materials pose a danger to the environment. Federal regulations require immediate reporting to specific agencies (federal and local) in the event of a release to the environment. We will cover the diferrent requirements, how to de...

  • Spill Prevention Control and Countermeasures (SPCC) Inspection Requirements

    Spill Prevention Control and Countermeasures (SPCC) Inspection Requirements

    Medical Sciences Fremont (California) November 17, 2020 Check with publisher

    Overview: The inspection requirements of the SPCC rule are designed to detect oil leaks, spills, or other potential integrity or structural issues before they can result in a discharge of oil to navigable waters of the U.S. or adjoining shorelines. R...

  • Personal Protective Equipment Requirements

    Personal Protective Equipment Requirements

    Medical Sciences Fremont (California) November 17, 2020 Check with publisher

    Overview: Personal protective equipment, commonly referred to as "PPE", is equipment worn to minimize exposure to hazards that cause serious workplace injuries and illnesses. These injuries and illnesses may result from contact with chemical, radiolo...

  • Validation and Use of Excel Spreadsheets in FDA Regulated Environments

    Validation and Use of Excel Spreadsheets in FDA Regulated Environments

    Medical Sciences Fremont (California) November 13, 2020 Check with publisher

    Overview: Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of ...

  • Useful Statistical Methods for Defining Product and Process Specifications

    Useful Statistical Methods for Defining Product and Process Specifications

    Medical Sciences Fremont (California) November 13, 2020 Check with publisher

    Overview: Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time. If specifications are too wide,th...

  • Secrets to Writing Effective SOPs for Medical Device QMS

    Secrets to Writing Effective SOPs for Medical Device QMS

    Medical Sciences Fremont (California) November 13, 2020 Check with publisher

    Overview: Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message t...

  • Understanding and Applying ICH Q3A and Q3B for Control of Impurities in Drug Substances

    Understanding and Applying ICH Q3A and Q3B for Control of Impurities in Drug Substances

    Medical Sciences Fremont (California) November 13, 2020 Check with publisher

    Overview: This course is designed to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants (including DNA reactive/potential genotoxic impurities) in drug substances and drug products. The...