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  • 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) April 20, 2021 1899.00 Dollar US$

    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...

  • The Veterinary Drug Approval Process and FDA Regulatory Oversight

    The Veterinary Drug Approval Process and FDA Regulatory Oversight

    Drug Development san Jose (california) December 18, 2020 1899.00 Dollar US$

    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...

  • Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

    Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

    Drug Development san Jose (california) December 18, 2020 1899.00 Dollar US$

    The globalization of the pharmaceutical supply chain has resulted in the increased use of Contract Manufacturing Organizations (CMOs). The use of CMOs provides many benefits; however, it also presents unique compliance risks, particularly since opera...

  • Data Integrity: FDA/EMA Requirements and Implementation

    Data Integrity: FDA/EMA Requirements and Implementation

    Data Management san Jose (california) May 22, 2021 1699.00 Dollar US$

    The integrity of data generated in support of marketing authorizations and in GMP, GCP and GLP regulated activities is foundational to sound decision making and regulatory compliance. Data integrity lapses are among the most serious concerns that pha...

  • Designing and Sustaining New and Existing Product Stability Testing Program

    Designing and Sustaining New and Existing Product Stability Testing Program

    Drug Development san Jose (california) May 15, 2021 1699.00 Dollar US$

    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...

  • The Veterinary Drug Approval Process and FDA Regulatory Oversight

    The Veterinary Drug Approval Process and FDA Regulatory Oversight

    Drug Development san Jose (california) May 15, 2021 1699.00 Dollar US$

    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...

  • FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

    FDA Audit, Quality Assurance Practices, Responsibilities and Expectations

    Drug Development san Jose (california) April 20, 2021 1699.00 Dollar US$

    This training will examine the differences between Quality Assurance and Quality Control and the responsibilities of each. In addition, attendees will discuss what characteristics quality personnel should possess. The current expectations for an effe...

  • Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

    Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

    Drug Development san Jose (california) April 20, 2021 1699.00 Dollar US$

    This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environ...

  • Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

    Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions

    Drug Development san Jose (california) April 17, 2021 1699.00 Dollar US$

    Raw material requirements in a cGMP environment are often overlooked as a Company develops new products. Depending upon the product being developed, e.g., tablets and capsules vs. biotechnology products to include recombinant microorganisms and gene ...

  • Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

    Lifecycle Management of Analytical Methods and Procedures according to new USP and ICH Guidelines

    Drug Development san Jose (california) December 19, 2020 1699.00 Dollar US$

    Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the regulated industry to have procedures in place to ensure suitable levels o...

  • Designing and Sustaining New and Existing Product Stability Testing Program

    Designing and Sustaining New and Existing Product Stability Testing Program

    Drug Development san Jose (california) December 18, 2020 1699.00 Dollar US$

    This Virtual Seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a ne...

  • Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

    Cleanroom, Microbiology and Sterility Assurance Practices for Drug and Device Manufacturers

    Data Management san Jose (california) December 18, 2020 1699.00 Dollar US$

    This course will educate you about various key elements of sterility assurance and contamination control such as Cleanroom Regulations, Classification, Sources and types of particles, Design Requirements, Validation/Qualification, Operations, Environ...