Biological Web-based Seminars

Early Intervention Field Trauma Training ... a Understand reactions and how to respond to Chemical/ Biological/ Radioactive/ Nuclear Terrorism a Identify emergency management, phases of disaster, and key concepts of disaster mental health a Discuss responder resiliency, prevention and self-care strategies COURSE EVALUATION: Students are required to attend all sessions or complete make-up assignments in order to successfully  more...

Auditing an Active Pharmaceutical Ingredient API Contract Manufacturing Organization CMO - Webinar By GlobalCompliancePanel ...manufacturing. You are purchasing more than a chemical or biological material. You are purchasing a material that can carry with it hidden risks if not properly examined and controlled. Such examination is not always productive if you rely simply on testing protocols. You need to learn where to look and what to focus on during any on-site audit. While understanding the applicable GMP is  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ... Pharmaceutical, Medical Device, Biotech, Diagnostics and Biological manufacturers. In August 2010, FDA made an announcement affecting virtually every drug, device and biologic firm marketing products in the U. S: "The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry's compliance and understanding of Part 11...The Agency intends to take appropriate  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...or those who are involved in producing pharmaceutical and biological products. Documentation is also needed as evidence that the training occurred. More and more frequently, regulatory agencies and their inspectors are requesting evidence that the training was effective. While regulatory agencies have these requirements and expectations, they give few specific details as to how the training is  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...uct composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design,  more...

Full Day Virtual Seminar - Designing and Implementing the Quality System for Combination Products - by GlobalCompliancePanel ...uct composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Although there are differences between these quality systems, the quality principles embodied in the systems are the same. This course looks at these principles and the processes associated with each principal to design,  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...ng which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with cGMP requirements for "single-entity" and "co-packaged" combination products. FDA proposes to create 21 CFR Part 4, subpart A,  more...