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Start: 07/27/2010 9:00 am
End: 07/27/2010 10:00 am
This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with.
Description :
Learn the basic skills required and how to apply them and the knowledge in becoming more effective.Manufacturers need to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system as well as assessing your GCP, GLP and GMP programs. Quality audits need to be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, need to be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, will be made and such reports certainly will be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits must be documented. This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.
Areas Covered in the seminar:
- Understand that audit preparation is critical and how to generate the audit plan.
- Learn the different type of audits and how to prepare, execute and close out the audit.
- Selecting your auditor or audit team and knowing the source of authority for conducting the audits.
- Development of checklists and using data collection methods.
- Know the expectations for audit performance, execution and auditing techniques.
- Understand the rules and expectations for audit reporting, corrective action, follow-up and closure .
- Learn the Do’s and Don’ts when auditing as related to FDA investigators/inspectors during inspections at your facilities.
- Understand the code of ethics, expectations, and how to write an effective audit report summarizing your findings.
Note: Use this Promo Code(101197) to avail Discount of 10% on LIVE Purchase.
Start: 07/27/2010 10:00 am
End: 07/27/2010 11:00 am
In this Food Safety training learn how your existing quality processes can be used for new and changing food safety requirements and problems.
Why Should You Attend:
Most companies are struggling to understand how they can come to grips with new and ever changing food safety requirements and problems. Most companies also have fairly sophisticated quality control systems already in place and most of the tools used in quality systems lend themselves readily to controlling food safety and associated problems. Companies relying heavily on lab and sampling approaches to implement food safety are ignoring the myriad of preventive approaches established as common quality control mechanisms over the past 100 years. This webinar will show how to use commonly implemented quality control to effectively control food safety.
Areas Covered in the Seminar:
- Don't let new terminology fool you: Process Controls or HACCP? Different names for the same concept.
- Ishikawa, Cause and Effect and applying this thinking to food safety.
- Continuous Improvement, TQM, 6-sigma concepts and the Feds.
- Thinking about closed-loop (self controlling) systems
- Integrating measurement, traceability, and data collection into a preventive rapid reporting system.
- The place of cycle time analysis in food safety
- Making food safety pay for itself (A quality cost approach).
- International Standards (ISO 22000 and ISO 22005).
Note: Use this Promo Code(101197) to avail Discount of 10% on LIVE Purchase.
Start: 07/27/2010 10:00 am
End: 07/27/2010 11:30 am
In this Product Risk Management webinar learn how to develop and implement product risk management planning. Understand the Key requirements of ISO 14971 and ICH Q9.
Why Should You Attend:
Both the U.S. FDA and the EU's MDD require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits. Companies are still not developing the required tools nor using them in all regulated / CGMP activities. When used, companies have not provided the documentation to allay investigators' / auditors' concerns. Existing risk documents are not used to their full potential
Areas Covered in the Seminar:
- Key requirements of ISO 14971 and ICH Q9.
- Suggested formats to meet both FDA and MDD requirements.
- Expected sources of information for evaluation and inclusion.
- How to compile.
- When to involve the team.
- How to complete, document and control as a 'living' document.
- An often neglected safety feature.
- Effectiveness -- Determining and Monitoring.
- Realizing real cost savings.
Note: Use this Promo Code(101197) to avail Discount of 10% on LIVE Purchase.
Start: 07/27/2010 11:00 pm
End: 07/27/2010 11:00 pm
Learn how to increase your New Business Pipeline by Labor Day!
If you or your sales team need more qualified appointments and a boost in sales then you need to tune into this Webinar.
In this Complimentary Webinar: Dean DeLisle, Founder and CEO of Forward Progress, will give you the Top 10 Techniques from their new Sales Program which uses LinkedIn as a core “Business Development Tool”.
ALL registrants and attendees will get access to the recording and materials.
Forward Progress has trained over 10,000 people on increasing targeted appointments therefore closing more sales – directly from LinkedIn!
With over 70,000,000 professionals on LinkedIn, you are closer to your targeted sales prospects than you think. Learn how to find them before your competitors do. You will also see what it takes to get THEM to find YOU – all while using LinkedIn less than 20 minutes a day!
In this brief session you will learn:
- Key profile settings
- Optimal LinkedIn system settings
- To find new business channels
- What content you need to use
- Where people search for experts
- What online leads look like
- How to organize your new leads
- How to track your success
- Free NEW tools to access
“Dean DeLisle is one of the foremost experts on using Social Networks for effective business marketing. Others offer introduction classes which provided me no value. Dean’s program got me up and running with immediate results to my bottom line.” — Darlene Ziebell, Executive Coach, Ziebell Enterprises, Inc.
Don’t miss this very new and exiting overview from the new Sales Training Programs being offered by Forward Progress.
We look forward to seeing you online in class!
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Start: 07/28/2010 10:00 am
End: 07/28/2010 11:00 am
This program helps managers master the art and science of performance documentation. Learn how to write behavioral documentation that protects your organization while promoting better performance from employees.
Why Should You Attend :
In our litigious society, it has become more & more important for supervisors to know how to document & discipline employees to avoid law suits and manage employee performance effectively. In this program, Judi gives managers a “crash course” in safe, legal, & effective disciplinary practices & documentation. You'll learn how to separate poor performance from poor attitude, counsel employees, & write Performance Improvement Plans. You'll learn how to keep a legal Performance Log to document both good & substandard performance. You'll learn how to implement your organization's disciplinary policy with confidence & accuracy.
Areas Covered in the seminar :
- Avoid the negative consequences of inadequate documentation & discipline.
- Utilize the range of disciplinary options.
- Respond quickly and appropriately to common disciplinary infractions.
- Keep a legal Performance Log.
- Counsel poor performers to encourage performance improvement.
- Distinguish between subjective and objective documentation.
- Work with employees to develop Performance Improvement Plans.
Note: Use this Promo Code(101299) to avail Discount of 10% on LIVE Purchase.
Start: 07/28/2010 10:00 am
End: 07/28/2010 11:15 am
Learn ISO 17025 - management, technical and documentation requirements. Understand Strategies for cost effective implementation.
Description:
The ISO 17025 standard is used by laboratories to develop and establish a Quality System for assessment by clients or third parties. ISO 17025 is now also being used as a criterion for laboratory accreditation.
ISO 17025 is applicable to all organizations performing tests and/or calibrations, regardless of the number of personnel or the extent of the scope of testing and/or calibration. Apart from in-depth data on requirements, this seminar also outlines a framework for cost-effective implementation.
Areas Covered in the seminar:
- Benefits of ISO 17025.
- Management requirements.
- Technical requirements.
- Documentation requirements.
- Steps towards ISO 17025 laboratory accreditation.
- ISO 17025 and agencies, such as US FDA.
- Impact on Analytical Laboratories.
- Recommendations for implementation.
- Dealing with multiple quality systems.
- Preparation for an ISO 17025 Audit.
- Local and global resources.
Note: Use this Promo Code(101299) to avail Discount of 10% on LIVE Purchase.
Start: 07/28/2010 11:00 am
Stop Speaking for Free
Learn the secrets to success with attendee-funded webinars
If you are a speaker intrigued by webinars as an income opportunity or an association desiring a non-dues revenue stream, join Lee Salz for this 60-minute webinar and you'll learn how to:
• Straddle the fine line between free and for-fee webinars … not all content is saleable
• Use one question to select the most saleable content … what people will readily pay to learn from you
• Avoid the most common mistake that causes no one to sign-up for your webinars
• Engage the 3 prospective registrant types effectively - and at the right time - so they sign-up for your webinars
• Leverage the webinar buying hot zone … the window when most registrations occur
• Select a title for your webinar that passes a 4-prong test
• Design your most important marketing tool … the webinar description
• Choose the right webinar provider for your campaign
The leading authority on attendee-funded webinars, Lee has helped hundreds of speakers, authors, trainers and consultants make money with webinars. The presentation is virtual, but the dollars are real.
"Stop Speaking for Free! teaches you everything you need to know to succeed with attendee-funded webinars. I’ve used these principles myself … and they work!"
– Patricia Fripp, Past National Speakers Association President and author of "Get What You Want! and Make It, So You Don’t Have to Fake It!"
About the Presenter
Lee B. Salz is the recognized authority on attendee-funded webinars. He has helped hundreds of speakers, consultants, trainers and authors stop giving their content away for free and make money delivering attendee-funded webinars. Lee launched Business Expert Webinars as a means to connect speakers with virtual audiences … and real dollars. In addition to Stop Speaking for Free!, Lee is also the author of the award-winning book Soar Despite Your Dodo Sales Manager. He's been quoted in the Wall Street Journal, New York Times, Dallas Morning News, MSNBC, Training Magazine, CBS News, ABC news and many other leading media groups.
Start: 07/28/2010 2:00 pm
Forrester Research says B2B marketers use LinkedIn more than any other form of social media, and for good reason. With over 70 million users and one million company profiles, LinkedIn is focused purely on business discussion and professional networking.
The demographics of the average LinkedIn user fit the background of the key decision makers in B2B environments. Join MLT Creative as we share best practices for using LinkedIn as part of your B2B marketing mix.
In this webinar you will learn to:
* Represent your personal brand and your company
* Optimize your profile to get found
* Increase your search rankings within LinkedIn
* Grow your network strategically
* Set weekly goals to build authority
Additionally, attendees will receive an eBook, a written reference guide for all best practices covered in the webinar, with added tips and checklists from LinkedIn expert, Viveka von Rosen.
Sign up for this free webinar to increase the likelihood prospects will access your LinkedIn profile, connect with you and become your clients.
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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
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.
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.
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.
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.
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Start: 07/30/2010 9:00 am
End: 07/30/2010 10:30 am
In this IT governance program Hear firsthand about the challenges, issues and rewards of implementing an IT Governance program, using an on-the-ground case study approach.
Why Should You Attend:
IT governance means different things to different people. To many, including regulators and auditors, IT governance is synonymous with compliance, yet business executives want more than regulatory compliance from IT Governance. They want to see accountability and clear decision rights over IT, they want measurable value created from their IT investments, they want to avoid being broadsided by unperceived IT risks, they want cost-effective IT security and they want IT to link and contribute to the organization’s strategy and performance drivers. A tall order indeed!
Areas Covered in the Seminar:
- The different approaches to implementing an IT Governance program.
- Why the business should be invested in IT governance.
- What IT governance really means to the business.
- Why we even need to sell IT governance to the business, especially if it is helping to get our ‘IT house’ in order and that is all the business needs or wants to know.
- The role of business executives in IT governance.
- Why getting the business engaged in IT decisions is so difficult and even more so, in getting business executives to accept accountability for committed project benefits and IT investments.
- How to sell IT governance and obtain buy-in and commitment from the business to develop and implement an IT Governance Program.
- Supplemented by case study examples of:
- Strategies used to sell IT governance to the business
- What worked and what did not work, lessons learned
- Implementation roadmap for an IT Governance Program
- How behavioral change was tackled
- Practices that have shown their value to the business
- Questions and answers.
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