Listings
  • Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

    Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties

    Life Sciences Philadelphia (Pennsylvania) July 5, 2018 Check with publisher

    Data Integrity: Learn to Comply with the FDA Expectations and Avoid Facing Penalties ranging from Public Warning Letters to Criminal Charges and Product Removal from the Market Place This seminar addresses the integrity of GxP records and data used w...

  • Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation

    Prepare Your Company to Comply with the New FDA FSMA Rules on the Sanitary Transportation

    Life Sciences Baltimore (Maryland) July 5, 2018 Check with publisher

    In this two-day workshop conference, you will learn the legal requirements, how to develop a company plan that meets FDA and your customer requirements. You will review and learn how to establish appropriate temperature monitoring, sanitation, contai...

  • 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...

  • Industrial Synthetic Biology Congress

    Industrial Synthetic Biology Congress

    Biology & Physiology Munich (Germany ) April 9, 2018 Check with publisher

    New advances in heterologous expression and biomolecular control systems are bringing about the biomanufacturing revolution. Join Oxford Global on the 8th – 9th October 2018 in Munich, Germany, to discuss the opportunities for chemical and natural pr...

  • Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance

    Computer Systems Validation Conference 2018 - 21 CFR Part11 Compliance

    Pharmacology - Drug Development Zurich (Zurich) April 2, 2018 Check with publisher

    Course "Validation and 21 CFR Part 11 Compliance of Computer Systems" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also kn...