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  • 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...

  • 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...

  • Information Technology - Control Procedures in Regulated Industries

    Information Technology - Control Procedures in Regulated Industries

    Training and Teaching Fremont (California) August 13, 2018 150.00 Dollar US$

    Overview: In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed. Why should you Attend: GxP/GMP regulations are required to be used in regulated indus...

  • When Conducting cGMP Regulatory Inspections 2018

    When Conducting cGMP Regulatory Inspections 2018

    Quality Control, Safety & Security Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA,...

  • When to Submit a 510(k) for a Change to an Existing Device

    When to Submit a 510(k) for a Change to an Existing Device

    Training and Teaching Fremont (California) June 15, 2018 290.00 Dollar US$

    Overview: This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) Why should you Attend: This presentation uses the latest FDA thinking and guidance documen...

  • Spreadsheets for 21 CFR 11 Compliance 2018

    Spreadsheets for 21 CFR 11 Compliance 2018

    Training and Teaching Fremont (California) June 15, 2018 150.00 Dollar US$

    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...

  • Historical Perspective of the Part 11 Regulation

    Historical Perspective of the Part 11 Regulation

    Training and Teaching Fremont (California) June 15, 2018 150.00 Dollar US$

    Overview: This presentation will provide an overview and historical perspective of the Part 11 regulation, the general Part 11 requirements,electronic records requirements, and electronic signatures requirements. Why should you Attend: Documented Par...

  • Controls Over Transportation of Fresh Organic Foods

    Controls Over Transportation of Fresh Organic Foods

    Chemical Methods Fremont (California) April 19, 2018 Free

    Overview: National Organic Program (NOP) standards were established in 2002. With almost every type of product now flying the "organic" flag from thousands of farms into hundreds of thousands of restaurants and retail establishments, the likelihood o...

  • What is the Regulatory Structure in Japan 2018

    What is the Regulatory Structure in Japan 2018

    Molecular Biology Fremont (California) April 19, 2018 Free

    Overview: This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and c...

  • How an Organization can remain Compliant with these Regulations

    How an Organization can remain Compliant with these Regulations

    Drug Development Fremont (California) April 19, 2018 Free

    Overview: Among those educational requirements are a course in Introductory GMP upon employment at a pharmaceutical company, and annual refresher GMP training. Why should you Attend: The laws that govern Good Manufacturing Practices (GMP) are a corne...

  • 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...

  • FDA FSMA Preventive Control Food Safety Plan

    FDA FSMA Preventive Control Food Safety Plan

    Training and Teaching Fremont (California) March 21, 2018 150.00 Dollar US$

    Overview: The plan must also include a hazard analysis, allergen analysis, factory profile, recall plan, supply chain controls, process preventive controls, sanitation preventive controls and other items. Why should you Attend: This "how to"webinar w...