Deviations Web-based Seminars

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - GlobalCompliancePanel Overview: Recent Consent Decrees have included requirements that the firm develop and implement systems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. Tuesday, June 19, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Effective Training Practices for FDA Compliance - Webinar GlobalCompliancePanel ...ate training of employees is one of most frequently cited deviations in FDA inspectional observations and warning letters. Trainings are either not planned, not conducted, not evaluated or not documented as expected by inspectors. On the other hand it has been is estimated that about 5% of employee's time is spent for training. So there seems to be lack of understanding on what the regulations  more...

Pharmaceutical Water System Use Monitoring Avoiding Problems by Doing It Right The Practicality of Real-Time Release - Webinar Overview: Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, February 2, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviation - Webinar By GlobalCompliancePanel Participants will obtain a greater insight into effective investigations and ways to identify the root cause and prevent a similar deviation in the future. Thursday, December 8, 2011 10: 00 AM PST | 01: 00 PM EST  more...

Troubleshooting Ethylene Oxide EO Processes - Webinar By GlobalCompliancePanel Not every parameter in the EO sterilization process in critical for the determination of the SAL. This presentation will outline the various parameters and what actions should be taken when they are not compliant to the process specification. Thursday, December 15, 2011 10: 00 AM PST | 01: 00 PM EST  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePan This Webinar deals with what happens, and under what circumstances, when the protocol is not followed (PNF) and why this is of particular significance. Covered, will be how a protocol deviation with the least significant effect where there is no substantive effect on the risks to research participants, no substantial effect of the value or integrity of the data, and did not result from willful  more...

Good Deviation Practice what you need to know-BY GCP This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/ CAPA system and thorough investigations  more...

Developing an Effective CAPA Strategy through Root Cause Analysis of Failures Deviations - Webinar By GlobalCompliancePanel Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This webinar highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis  more...

A Comparison of the Pharmaceutical and Medical Device Good Manufacturing Practices - A Study of Similarities and Differences - W ...istribution, & Returns * Module 15 - Problem Solving-Deviations, Complaints, and CAPA * Module 16 - How about Part 11 * Module 18 - Current Trends * Module 17 - Review and Wrap-up Who Will Benefit: * Quality, quality control, regulatory affairs, operations working in the FDA regulated medical products industry (Pharma & Device) in the design, scale-up, regulatory  more...

The Investigation System Discovery Planning Root Cause Analysis CAPA - Webinar By GlobalCompliancePanel ...e concerned with the analysis and correction of problems (deviations and failures). This course provides clarity to the regulatory expectations and guidance, and to the essential skills necessary to ensure effective and efficient investigations. Topics will examine each step of the investigation process from failure identification and notification through documentation. Participants will  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...tems that result in timely and complete investigations of deviations and corrective and preventive actions that address the root cause of deviations. FDA 483 and Warning letter observations identify inadequate investigations and follow-up. This webinar addresses adequate investigation of deviations. Participants will obtain a greater insight into effective investigations and ways to identify  more...

Designing and Implementing the Quality System for Combination Products - Webinar By GlobalCompliancePanel ...ministrative" Process Controls Module 8: Introduction to Deviations & Quality Failures (0: 10) Module 9: Validation Module 10: Maintaining Label Control-From Design to Label Application Module 11: Storage and Distribution & Returned and Salvaged Products Module 12: Returned and Salvaged Products Module 13: Laboratory Controls Module 14: Problem Solving-Nonconforming, Investigations, and  more...

Understanding and Preparing for FDAs New Part 11 Inspection Program - Webinar By GlobalCompliancePanel ...on Part 11 and computer validation: most frequently cited deviations * How to fill gaps short term * Developing a program for long term * Creating the right documentation to satisfy the inspectors * Most likely next steps after the inspection program Who will benefit: * IT managers and system administrators * QA managers and personnel * QC and Lab  more...

How to Prevent or Handle Protocol Deviations and Violations to be GCP and Regulatory Compliant - Webinar By GlobalCompliancePane ...are differences in actions, reporting and consequences of deviations and violations and these will be discussed. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. TO not follow the protocol is folly. Why Should You Attend: Protocol Deviations and Violations are one of the most common problems  more...

Auditing API Manufacturers and Suppliers - Webinar by GlobalCompliancePanel ...oblems. Being able to find hidden signs of weakness or deviations that are not obvious are key to a good audit. Developing that talent and utilizing it are vital to the success of an audit and the auditor. Being able to discover "the smoking gun" is a key talent of a great auditor. It is always easy to criticize after a problem causes a serious issue . . . it is difficult to see the  more...