Overview: Post market surveillance is changing, not only in the US, but also in the EU and Canada.
Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated - Webinar By GlobalCompliancePanelSubmitted by globalcomplianc... on Fri, 10/02/2012 - 12:19
Overview: This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies.
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans - Webinar By GlobalCompliancePanelSubmitted by globalcomplianc... on Fri, 10/02/2012 - 12:18
Overview: This course provides the attendees with the tools needed to understand and implement acceptance sampling. We explain the basis for sampling plans, the binomial distribution, and show how it helps us understand the sampling plan's performance using the operating characteristic (OC) curve.
Overview: Attend this webinar to understand the differences and benefits of verification and validation. Learn about the risks and complications involved with the application of sound verification and validation principles.
Overview: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health.
Overview: This webinar will give a good understanding of FDA and international expectations for auditing computer systems and provide steps for cost-effective implementation.
21 CFR Part 11 and Annex 11; What you Need to Know to Pass the New Regulatory Audits - Webinar By GlobalCompliancePanelSubmitted by globalcomplianc... on Fri, 10/02/2012 - 12:03
Overview: This webinar details both regulations and provides details for implementing computerized systems.
Overview: This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.
Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCompliancePanelSubmitted by globalcomplianc... on Fri, 10/02/2012 - 12:00
Overview: FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.
DHF, DMR, DHR, and the Technical File-Design Dossier - Similarities and Differences - Webinar By GlobalCompliancePanelSubmitted by globalcomplianc... on Fri, 10/02/2012 - 11:57
Overview: This webinar will examine the existing and proposed requirements for the FDA's DHF -- including its derivative documents, the DMR and DHR.