• Ashutos Swain

Latest listings

  • Data Integrity: FDA, WHO and EMA's Requirements

    Data Integrity: FDA, WHO and EMA's Requirements

    Laboratory Equipment and Instrumentation san Jose (california) August 27, 2021 1299.00 Dollar US$

    Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a world-wide basis, the FDA has been reporting its occurrence off-shore w...

  • SOP Writing, Training and Compliance in the Pharmaceutical Industry

    SOP Writing, Training and Compliance in the Pharmaceutical Industry

    IT san Jose (california) August 27, 2021 1299.00 Dollar US$

    Standard Operating Procedures (SOPs) are the basis for a large part of the day-to-day training that most pharmaceutical employees are required to perform. Still, it is not widely understood the extent of the commitments we make when we write an SOP o...

  • The Veterinary Drug Approval Process and FDA Regulatory Oversight

    The Veterinary Drug Approval Process and FDA Regulatory Oversight

    Pharmacology - Drug Development san Jose (california) August 27, 2021 Check with publisher

    The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process f...

  • Essentials Of USP Microbiology

    Essentials Of USP Microbiology

    Pharmacology - Drug Development san Jose (california) August 27, 2021 Check with publisher

    The objective of this on-line, interactive two day "Essentials of USP Microbiology" seminar is to explore USP General and General Information Chapters to learn their current and updated status and to confirm that those Chapters being utilized are use...

  • Designing and Sustaining New and Existing Product Stability Testing Program

    Designing and Sustaining New and Existing Product Stability Testing Program

    Pharmacology - Drug Development san Jose (california) August 27, 2021 Check with publisher

    New or existing modified drug Stability Testing Program's regulations/requirements stipulated by the FDA, 21 CFR or other regulations may sometimes creating an overwhelming situation based on the type of product that is being manufactured. Hence, som...

  • Method Development and Validation for Assays Supporting Testing of Biologics

    Method Development and Validation for Assays Supporting Testing of Biologics

    Clinical/Medical Sciences san Jose (california) August 27, 2021 Check with publisher

    Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. Thi...

  • Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!

    Case Management Boot Camp: Strategies for Success in the Acute Care Setting and Beyond!

    Medical - Health san Jose (california) August 27, 2021 Check with publisher

    Please join us for this intense one-day program that will give you the skills to succeed as a case manager or social worker in the new era of value-based reimbursement and accountable care. The world of healthcare is changing so rapidly and so is the...

  • Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

    Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

    IT san Jose (california) August 19, 2021 229.00 Dollar US$

    Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time. This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft ...

  • Data Integrity Compliance for Computer Systems Regulated by FDA

    Data Integrity Compliance for Computer Systems Regulated by FDA

    Medical - Health san Jose (california) August 19, 2021 Check with publisher

    Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. In this webinar, you will learn about these FDA trends in compliance and enforcement, as they relate to Data Integrity, and how to imp...

  • Writing and Revising SOPs for Increased Operational Efficiency

    Writing and Revising SOPs for Increased Operational Efficiency

    Drug Development san Jose (california) June 26, 2021 199.00 Dollar US$

    Are new staff confused during training on your SOPs? Do you have too many SOPs? Do some SOPs give directions that conflict with directions from other SOPs? Are you writing up deviations far too often? Do you have some SOPs that just plainly don’t mak...