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  • 2-day In-person Seminar FDA and U.S. Customs Import Rules and Export Traps in 2020

    2-day In-person Seminar FDA and U.S. Customs Import Rules and Export Traps in 2020

    Quality Control, Safety & Security Washington (Washington, DC) August 8, 2019 2000.00 Dollar US$

    FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence to government procedures. Firms that fail to understand and properly execute an imp...

  • 2-day In-person Seminar Applied Statistics for FDA Process Validation

    2-day In-person Seminar Applied Statistics for FDA Process Validation

    Other Services Philadelphia (Philadelphia, PA) August 8, 2019 2000.00 Dollar US$

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates...

  • 2-day In-person Seminar Death by CAPA - Does your CAPA Program need a CAPA?

    2-day In-person Seminar Death by CAPA - Does your CAPA Program need a CAPA?

    Training and Teaching Philadelphia (Philadelphia, PA) August 8, 2019 2000.00 Dollar US$

    This 2-day seminar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. You'll learn how to streamline and monitor your process to ensure compl...

  • 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 ...