• Ashutos Swain

Latest listings

  • Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

    Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)

    Drug Development san Jose (california) March 2, 2021 Check with publisher

    Today, many companies operate on an outsourcing model. This is very common for companies who are evolving from being mainly development-focused to a point where they are entering latter stages of Phase 2 or Phase 3 clinical trials, and plan to have a...

  • Global Regulations for Equipment Qualification and Validation of Processes

    Global Regulations for Equipment Qualification and Validation of Processes

    Pharmacology - Drug Development san Jose (california) March 2, 2021 Check with publisher

    The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing equipment. The FDA's findings of deficiencies concerning equipment validation indicate the agencies expect definitiv...

  • PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

    PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation

    Drug Development san Jose (california) March 2, 2021 Check with publisher

    The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requi...

  • Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

    Ensuring Compliance with Advertising and Promotional Requirements for Drugs and Medical Devices

    Pharmacology - Drug Development san Jose (california) March 2, 2021 Check with publisher

    Federal regulation of the advertising and promotion of pharmaceuticals and medical devices reflects an aggressive attitude on the part of the regulators that demands, in turn, that industry be keenly aware of the legal and regulatory duties, as well ...

  • Implementing UDI (Unique Device Identification) - Plan Now for Success

    Implementing UDI (Unique Device Identification) - Plan Now for Success

    Medical Sciences san Jose (california) February 25, 2021 Check with publisher

    The one-day virtual seminar provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter. The virtual seminar gives you han...

  • Navigating through Maze of In-vitro Diagnostics (IVD) Regulations

    Navigating through Maze of In-vitro Diagnostics (IVD) Regulations

    Medical Sciences san Jose (california) February 25, 2021 Check with publisher

    In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set...

  • Risk Management in Medical Devices Industry

    Risk Management in Medical Devices Industry

    Medical Sciences san Jose (california) February 16, 2021 Check with publisher

    Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harm to patients, users...

  • Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

    Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies

    Clinical san Jose (california) February 16, 2021 Check with publisher

    This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those who o...

  • Implementing the 2021 Guidelines for Office and Outpatient Visits

    Implementing the 2021 Guidelines for Office and Outpatient Visits

    Medical - Health san Jose (california) February 16, 2021 Check with publisher

    The current guidelines for documentation of office and outpatient visits were implemented in the early 90’s and have become cumbersome and outdated for the current medical provider. For 2021 CMS and the AMA have joined together to create and implemen...

  • Medical Device Cybersecurity Risk Management Training

    Medical Device Cybersecurity Risk Management Training

    Medical Sciences san Jose (california) February 16, 2021 Check with publisher

    This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.