Calibration 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...

Equipment Validation Tracking Calibration and Preventive Maintenance - GlobalCompliancePanel Overview: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, April 18, 2012 10: 00 AM PDT | 01: 00 PM EDT  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Wednesday, December 14, 2011 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...

Does your Equipment Program Meet Current Regulatory Expectation - Webinar By GlobalCompliancePanel 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. Thursday, October 20, 2011  more...

Equipment Validation Tracking Calibration and Preventive Maintenance - Webinar By GlobalCompliancePanel FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. Thursday, October 20, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

Calibration Concepts for Auditors and Reviewers - Webinar By GlobalCompliancePanel This presentation will provide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option.  more...

Calibration and Qualification in Analytical Laboratories - Webinar By GlobalCompliancePanel ...mpact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document. For easy implementation, attendees will receive: * 4 SOPs o User Requirement  more...

Understanding the Calibration Curve - Webinar By GlobalCompliancePanel ...ovide an overview of the rules and assumptions behind the calibration of analytical instruments. We will discuss how external standard, internal standard, and isotope dilution methods are designed, and learn the situations where each technique is the best option. Whether you use single point calibration, or linear regression, we will discuss the strengths and weaknesses of each approach. If  more...

Does your Equipment Program meet current regulatory expectations - Webinar By GlobalCompliancePanel ...he 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 should attend: The equipment Program is a critical component of both GMP and GLP laboratories. It contributes to the quality and therefore reliability of the generated data which is  more...

Avoiding FDA 483 Observations by Identifying the Root Cause of Deviations - Webinar By GlobalCompliancePanel ...omplaints, audit observations, deviations, discrepancies, calibration out-of-tolerances * FDA expectations for investigations * The investigation-problem resolution process - understand the problem, identify possible causes, data collection, data analysis, root cause identification, root cause elimination, solution implementation, verify success * Tools for understanding the  more...

Analytical Instrument and Equipment Qualification in Quality Laboratories - Webinar By GlobalCompliancePanel ...ed in a simple and understandable way. The interaction of calibration, qualification, method validation and equipment maintenance on laboratory compliance and data quality will be discussed. Why should you attend: The analytical instruments and laboratory equipment are easy targets for inspectors looking to cite observations of non-compliance. Are yours ready for the internal QA and  more...

A Comparison of ICH Q-10 Quality System and the FDAs Quality Systems Approach QSA to the Pharmaceutical GMPs - Webinar By Global Overview: In September of 2006, the FDA published the Quality System Approach to Pharmaceutical Good Manufacturing Practices which provided a quality orientation to the GMP's Then in June of 2008, The International Conference on Harmonization (ICH) published ICH-Q10, Pharmaceutical Quality System. These guidance documents have provoked thought and raised questions about existing pharmaceutical.  more...

Regulatory Requirements for Medical Device Calibration Programs - Webinar by GlobalCompliancePanel ...Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement. The presentation states with the regulatory requirements in the FDAa ™s QSR, ISO 13485, and ISO 9001. After analysis  more...