Training and Teaching

Listings
  • Concise SOPs that your (Employees) can Easily Follow

    Concise SOPs that your (Employees) can Easily Follow

    Training and Teaching Fremont (California) October 11, 2018 Free

    Overview: Every biopharmaceutical company has SOPs, and new staff members are told that the company "has to have them" and that each employee "has to follow them". But why do there have to be SOPs and why must we follow them as written? And how can w...

  • Label Promotion of Drugs and Medical Devices 2018

    Label Promotion of Drugs and Medical Devices 2018

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents. Why should you Attend: This session will discuss commen...

  • Current Concepts and (Future Trends) for Effective Immunization

    Current Concepts and (Future Trends) for Effective Immunization

    Training and Teaching Fremont (California) October 11, 2018 Free

    Overview: How to choose the vaccine for different age groups. The nasal influenza vaccine. Quadrivalent cell culture vaccine. Non egg adapted influenza vaccines for kids. Recent advances and future developments will be discussed. Areas Covered in the...

  • Where Does your Organization Stand?

    Where Does your Organization Stand?

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: We will discuss the pro's and con's of a implementing a zero incident workplace culture and describe how to determine if you are doing it right. Why should you Attend: A zero injury workplace safety cultures consist of shared beliefs, pract...

  • Why Organizations need to use CAPA, What is its Purpose?

    Why Organizations need to use CAPA, What is its Purpose?

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: In this webinar, we will review CAPA as part of Quality Management System (QMS), reasons why organizations need to use CAPA, what is its purpose. We will describe CAPA concepts and procedures. We will also describe FDA investigation procedu...

  • How to Conduct Effective Close out Meetings

    How to Conduct Effective Close out Meetings

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your ex...

  • Future Trends in 21 CFR 11 compliance for (Excel Spreadsheets)

    Future Trends in 21 CFR 11 compliance for (Excel Spreadsheets)

    Training and Teaching Fremont (California) October 11, 2018 Free

    Overview: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. Areas Cov...

  • FDA Policy and Goals Regarding the 483 Response - 2017

    FDA Policy and Goals Regarding the 483 Response - 2017

    Training and Teaching Fremont (California) April 20, 2017 Free

    Overview: FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Lette...

  • What Sponsors Expect and How to Meet their Expectations

    What Sponsors Expect and How to Meet their Expectations

    Training and Teaching Fremont (California) April 19, 2018 Free

    Overview: It is essential for industry to employ efficient and accurate strategies for monitoring outsourced projects to minimize the chances of receiving warning letters from competent authorities. Companies should have robust structures in place fo...

  • SOP Development - How to Write Them Effectively For Compliance - 2017

    SOP Development - How to Write Them Effectively For Compliance - 2017

    Training and Teaching Fremont (California) April 20, 2017 Free

    Overview: This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of...

  • Steam Sterilization Microbiology and Autoclave Performance - 2017

    Steam Sterilization Microbiology and Autoclave Performance - 2017

    Training and Teaching Fremont (California) April 20, 2017 Free

    Overview: Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. Why should you Attend: Sterilization process parameters will be laid out as a basis for conducting autoclave perform...

  • Software Validation Program That will Satisfy FDA Requirements - 2017

    Software Validation Program That will Satisfy FDA Requirements - 2017

    Training and Teaching Fremont (California) April 20, 2017 Free

    Overview: This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. Why should you Attend: Testing software to prove that it works and has no bugs is not sufficient to obtain FD...