Pharmacology - Drug Development

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  • Change Control Best Practices - Avoiding Unintended Consequences of Changes

    Change Control Best Practices - Avoiding Unintended Consequences of Changes

    Pharmacology - Drug Development san Jose (california) December 18, 2020 Check with publisher

    One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely impact...

  • Data Integrity: FDA/EU Requirements and Implementation

    Data Integrity: FDA/EU Requirements and Implementation

    Pharmacology - Drug Development san Jose (california) December 18, 2020 Check with publisher

    Data integrity has been a focus for pharmaceutical regulatory inspections for a number of years and look set to remain of concern to regulators and manufacturers for many years to come. Many inspection reports from regulatory agencies around the worl...

  • Assess Impact For Supplier Change Notices

    Assess Impact For Supplier Change Notices

    Pharmacology - Drug Development san Jose (california) December 12, 2020 Check with publisher

    This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.

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

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

    Pharmacology - Drug Development san Jose (california) November 28, 2020 Check with publisher

    In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed o...

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

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

    Pharmacology - Drug Development san Jose (california) November 28, 2020 Check with publisher

    In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies. You will learn how to diagnose your company's needs based on which GMP and GCP-governed o...

  • 6-Hour Virtual Seminar on Stress Management

    6-Hour Virtual Seminar on Stress Management

    Pharmacology - Drug Development Fremont (California) August 7, 2020 Check with publisher

    Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less ...

  • 6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020

    6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020

    Pharmacology - Drug Development Online Event (California) January 17, 2020 Check with publisher

    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection ...

  • 6-Hour Virtual Seminar on FDA's Software Monsters

    6-Hour Virtual Seminar on FDA's Software Monsters

    Pharmacology - Drug Development Fremont (California) January 17, 2020 Check with publisher

    The complexity and vulnerability of software is expanding exponentially, so fast that Congress removed some device software from FDA’s jurisdiction. The remaining software regulated by FDA presents a degree of a risk to health that creates a public h...

  • 6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020

    6-Hour Virtual Seminar on Tougher Import Rules for FDA Imports in 2020

    Pharmacology - Drug Development Online Event (California) January 17, 2020 Check with publisher

    Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained. Likewise, the U.S. Customs and Border Protection ...

  • Effective Complaint Handling, Medical Device Reporting and Recalls

    Effective Complaint Handling, Medical Device Reporting and Recalls

    Pharmacology - Drug Development Baltimore (Maryland) December 6, 2019 Check with publisher

    An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corr...

  • HIPAA, Consents, and 42 CFR Part 2

    HIPAA, Consents, and 42 CFR Part 2

    Pharmacology - Drug Development Fremont (California) December 4, 2019 Check with publisher

    Overview: For much of healthcare, HIPAA sets the standards for how to manage uses and disclosures of patient information, known as Protected Health Information (PHI). But when it comes to information related to the treatment of substance use disorder...

  • Physician Employment Agreements: Items to Consider

    Physician Employment Agreements: Items to Consider

    Pharmacology - Drug Development Fremont (California) October 22, 2019 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...