Events

Select event terms to filter by

« Thursday July 29, 2010 »
Thu
The Seven Keys for Effective Solid Dosage Manufacturing Start: 07/29/2010 2:15 am The best manufacturing companies follow "key steps" that set them apart from the typical solid dosage manufacturing company. - Learn what techniques they consider to be the "best" and how to implement them - Discover ‘the seven keys’ to becoming a cost-effective solid dosage manufacturer with a competitive advantage - Get the tools to implement a fully integrated learning system that will combine SOP's, batch records, theory, and actual employee function Key elements that make solid dosage manufactures more competitive and efficient while achieving and maintaining the highest product quality possible: • Understanding and following SOP's • Employing a GMP mentality • Maintaining equipment function • Managing the supply chain • Environmental controls to maintain forward motion Each successful team must: • Expect problems and know how to react • Have clearly defined and effective procedures • Consistently educate everyone, with clear repeatable objectives • Ensure team members have the right tools & guidelines to help everyone do a better job This is a must attend webinar for Managers, Supervisors, and those of you involved in the production of tablets & capsules, R&D, Technical Services, Engineering, Quality Assurance, Quality Control, or Purchasing. Technical Requirements - PC headset - PC speakers - Broadband Connection How do I keep FDA happy with my contract manufacturer? Start: 07/29/2010 9:00 am End: 07/29/2010 10:00 am This Quality System Regulation training we will review the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined. Why Should You Attend : Many companies are confident that their design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue. This presentation will review the sections of the QS Reg. design control regulation which represent high compliance risk to firms. Actual design control/FDA data will be discussed, which shows the agencies' design control compliance directions. FDA investigator techniques will also be discussed. Learning Objectives: What FDA expects and will request from you during your design control portion of your FDA inspection. How QSIT inspections related to design control systems and its attendant record keeping are performed by FDA. How change control issues affect design control inspections. What constitutes a good design control process auditing procedure. How do how to counteract a possible design control FDA 483 cite. How risk management fits into design control compliance. Areas Covered in the Seminar: Introduction. Guidance documents QS regulation. Major FDA 483 points. Trends in FDA. Determining best practice for the supplier audit. Conducting a thorough audits. FDA import detention prevention. Questions to ask during the supplier audit. Questions & Answers. Note: Use this Promo Code(101460) to avail Discount of 10% on LIVE Purchase. Decoding CLIA (Clinical Laboratory Improvement Amendments) Regulations: Calibration, Calibration Verification and Method Validation Start: 07/29/2010 10:00 am End: 07/29/2010 11:00 am The Clinical Laboratory Improvement Amendments (CLIA) training will outline the CLIA standards for frequency, methodology and also give examples of practical application. Description: The terms calibration, calibration verification and method validation are sometimes used interchangeably. The reality is that all of these are distinctly different processes and are all required by CLIA as related to medical laboratories. This presentation will explore the definitions, distinctions and rules of all three. The Clinical Laboratory Improvement Amendments presentation will outline the CLIA standards for frequency, methodology and give examples of practical application. These rules have been in place since 2003 and compliance will be judged on inspections by CLIA, JCAHO, COLA, CAP and AAB. This presentation will give outlines for compliance and address basic formulas used to calculate precision, accuracy etc. Areas Covered in the seminar: What do calibration, calibration verification and method validation mean? When each of these processes should take place. What systems are required to use these processes and which ones are not. Requirements for validation of new test systems. Remedial action if these processes are unsuccessful or have unexpected results. Reasoning behind each process and why they are necessary. Troubleshooting ethylene oxide (EO) processes Start: 07/29/2010 10:00 am End: 07/29/2010 11:30 am This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification. Why Should You Attend: Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. Many anomalies occur during qualification or routine processing and may come in the form of sterilization cycle parameter that is not achieved or a positive biological indicator. Not knowing how to respond to these situations can result in a response that results in the release of product that might not meet the required sterility assurance level (SAL) or the needless re-sterilization of product. Regulatory action can result from the prior while additional expense to the company can result from the latter. But not every parameter in the EO sterilization process in critical for the determination of the SAL. Areas Covered in the Seminar: What is a cycle anomaly. What cycle specifications are critical for sterilization. What cycle specifications are critical for product residuals. Actions to be taken for critical deviations/anomalies. Actions to be taken for non-critical deviations/anomalies. What testing can be performed to justify product release. Developing a specification to address actions. How to document your rationale. Note: Use this Promo Code(101460) to avail Discount of 10% on LIVE Purchase. Why Managed Online Data Backup? Start: 07/29/2010 3:00 pm End: 07/29/2010 3:30 pm Exponential data growth brings with it many tough challenges for modern business. IT teams are struggling to ensure data availability under tight fiscal constraints. Online backup, offered as a managed service, answers these challenges by leveraging existing server and network infrastructures to securely and efficiently protect servers and key applications against data loss. Its ability to immediately move backed up copies of data securely off-site, away from any potential site disaster, is a key differentiator. Automation and deduplication, as well as greater security, reliability, and easier, more centralised administration, suggest that online backup is the right choice for businesses that are serious about protecting their business-critical data. Learn more about Managed Online Data Backup, register for our upcoming webcast here: http://www.intechnology.co.uk/webcasts.