Contents Web-based Seminars

Accelerated PMP E Learning Introduction: This training program is conducted to expose the participants to an integrated approach to Project Management. It is designed to develop the necessary knowledge needed to manage projects effectively. Key Features: Live Online sessions, 7 lectures of 3 hrs each only on weekends, to continue for 4 weeks. Opportunity to discuss directly with the faculty & clarify all  more...

Advanced Adobe InDesign CS4 Training This Adobe InDesign training class covers advanced features of InDesign CS4. Students will learn to work with variables and cross references, to create books with a table of contents and index, to output documents in multiple formats, to work with XML and to create interactive PDFs.  more...

GMP for Phase 1 Products - Webinar By GlobalCompliancePanel Overview: This presentation will cover the contents of the guidance that was given. FDA has issued as rule that relieves Phase 1 products from complying with the GMP given in 21 CFR 211. At the same time, they ruled that the products must continue to comply with the GMP as given in the Food, Drug, and Cosmetic Act. Guidance was then given to describe these GMP. Tuesday, August 7, 2012 10: 00  more...

FDA Requirements for Device Labeling Development Contents Distribution and Changes - Webinar GlobalComplianceP Overview: Marketing wants to entice customers to buy your product instead of your competitor's! A common method is to make the labeling as eye-catching as possible. Wednesday, May 16, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

The 510k Submission Requirements Contents and Options - Webinar GlobalCompliancePanel 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. Tuesday, March 20, 2012 10: 00 AM PST | 01: 00 PM EST  more...

How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare by GCP This webinar will provide valuable assistance to all companies that market in the U. S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.  more...

The 510k Submission Requirements Contents and Options - Webinar by GlobalCompliancePanel 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. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish  more...

DHF DMR DHR Technical File and Design Dossier - Key Requirements and Future Directions - Webinar By GlobalCompliancePanel ...ments' differing purposes / goals. Required and desirable contents will be discussed. Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity";  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...y File (DHF) o Definition o Typical contents o DHF and outsourced design/ production o DHF and OEM relationships * Device Master Record (DMR) o Definition o Typical contents o DMR and outsourced design/ production o DMR and OEM relationships o Controlling and maintaining DMR * Device  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ...y File (DHF) o Definition o Typical contents o DHF and outsourced design/ production o DHF and OEM relationships * Device Master Record (DMR) o Definition o Typical contents o DMR and outsourced design/ production o DMR and OEM relationships o Controlling and maintaining DMR * Device  more...

The DHF Technical File and Design Dossier - Similarities Differences and The Future - Webinar by GlobalCompliancePanel ...goals. Differing purposes / goals. Required and desirable contents. Areas requiring frequent re-evaluation / update. Similiarities and differences, and future trends. Typical DHF Table of Contents. Technical File or Design Dossier Table of Contents. The importance and usefulness of the "Essential Requirements". Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed.  more...

The 510k Submission Requirements Contents and Option ...inar on the topic of The 510(k) Submission: Requirements, Contents, and Option. Webinar will be on March 4, 2010. Webinar will be presented by Jeff Kasoff. Mr. Kasoff is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with  more...