Citations Web-based Seminars

Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco ...ittle is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide guidance on how your company can ensure that they have a successful inspection. Date & Venue May 03rd and  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ... these questions answered. Why should you attend: Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant  more...

The Most Common Problems in FDA Software Validation Verification- Webinar By GlobalCompliancePanel ...rutiny. * A third of recent warning letters included citations with respect to improper or ineffective validation. * Many companies struggle with understanding how to avoid major mistakes when validating software to FDA standards. This presentation will review the validation planning process with particular emphasis on avoiding common pitfalls. The attendee should leave the  more...

Best practices for conducting OOS investigations - Webinar By GlobalCompliancePanel ...tions in the coming months and years. The large number of citations indicates that though the regulations in this area have not changed, they are either not well understood or that organizations face practical difficulties in complying with them. Areas Covered In the Seminar: * FDA requirements for handling OOS/ OOT results * Phase I- Laboratory Phase of Investigations *  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel Overview: This Interactive webinar will begin with an overview of the GMP/ GLP requirements for an Equipment system. The procedure for Equipment Qualification will be discussed. The system elements required to manage the maintenance and calibration of all equipment in the laboratory will be discussed. The documentation which is critical for GMP/ GLP compliance will be reviewed. Why you  more...

Effective Training Practices for FDA Compliance - Webinar By GlobalCompliancePanel ...rom different regulatory bodies (from the regulations and citations), attendees will be able to envision what to include in a GMP training program. In addition, an overview of the training system, including types of training planning, will offer considerations to make GMP training more effective. Why you should attend: Regulatory agencies around the world require that training on good  more...

Why is CAPA so often cited in medical device inspections - Webinar By GlobalCompliancePanel ...rs. Areas Covered in the Session: * Review CAPA citations in FDA-483 and Warning Letters * Identify common problems with CAPA * Identify FDA CAPA regulatory requirements * Identify ISO 13485 CAPA requirements * Explore FDA's risk expectations of CAPA systems * Establishing a risk-based CAPA system Who Will Benefit: * Regulatory Management *  more...

Medical Device Reporting Regulations and Violations - Webinar By GlobalCompliancePanel ... As part of the review, actual Warning Letter and FDA-483 citations of small and large medical device manufacturers will be explored for Medical Device Reporting issues. There is a great deal of concern at FDA over the quality of the information being reported and the timeliness. Some at FDA are concerned that manufacturers have not placed adequate attention to following these regulations,  more...

Design History File DHF Device Master Record DMR Device History Record DHR and Technical File TF - Regulatory Documents Explaine ... these questions answered. Why should you attend: Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming, in-process and finished products. Is your company able to access all relevant  more...