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Text[0]=["CCMS Best Practices","This free webinar discusses how your Computerized Calibration Management System can help you make the most of limited calibration resources.<br>Duration: 1 hour<br>Cost: Free"]
Text[1]=["Calibration Program","This web training course discusses the development of a calibration program, including elements of a master plan, program SOPs and calibration SOPs and documentation.<br>Duration: 2 hours<br>Instructor: Marcus McNeely<br>Cost: $295"]
Text[2]=["Minimizing Calibration Risk in Complex Biotech Environments","The biotech industry's risks -- including scientific, regulatory and business risks -- are unique.  This web training discusses these risks, the unique complexities of the biotech industry and the strategies and tools available to reduce those risks.<br>Duraction: 1 hour<br>Instructor: Marcus McNeely<br>Cost: $150"]
Text[3]=["Determination of Process and Calibration Tolerances and Correcting OOT","This web training course discusses approaches for determining process and calibration tolerances and strategies for correcting out of tolerance conditions and reducing OOT occurences.<br>Duration: 2 hours<br>Instructor: Marcus McNeely<br>Cost: $295"]
Text[4]=["Assessing Calibration Standards","This web training course offers a complete review of the worldwide system to control standards and techniques for assessing standards used for calibration.<br>Duration: 2 hours<br>Instructor: Marcus McNeely<br>Cost: $295"]
Text[5]=["Qualifying and Managing Calibration Laboratories and Onsite Contractors","This web training course discusses techniques for avoiding common pitfalls with calibration contract laboratories and onsite calibration contractors, including how to choose appropriate partners for your business.<br>Duration: 2 hours<br>Instructor: Marcus McNeely<br>Cost: $295"]
Text[6]=["Introduction to Measurement Uncertainty","This web training course offers a foundational understanding of the importance of measurement uncertainty, the philosoophies on how to calculate it and how to use it to improve calibration results.<br>Duration: 1 hour<br>Instructor: Marcus McNeely<br>Cost: $150"]
Text[7]=["There is a difference: maintenance management designed for the life sciences","This free webinar discusses the unique maintenance requirements within the life science industry and how Blue Mountain Regulatory Asset Manager can significantly simplify complying with those unique requirements.<br>Duration: 1 hour<br>Cost: Free"]
Text[8]=["Managing Compliance Processes for Maintenance in Life Sciences","This web training course discusses the compliance processes required in maintenance and approaches for implementing those processes while still maintaining productivity.<br>Duration: 2 hours<br>Instructor: Marcus McNeely<br>Cost: $295"]
Text[9]=["Improving Productivity:<br>collaboration, harmonization and KPI","This free webinar offers practical advice for improving productivity for a complete engineering department which may include calibration, maintenance and validation through collaboration, harmonization and key performance indicators."]
Text[10]=["Facilities and Equipment Subsystem of QSIT","This two-day regional training establishes the components of the Facilities Equipment subsystem of the Quality Systems Inspection Technique, its importance and an overview of the basics needed to meet regulatory and good manufacturing requirements, including facility equipment qualification, cleaning, performance qualification, maintenance and calibration requirements.<br>Duration: 2 Days<br>Instructor: Joe Busfield<br>Cost: $1500<br><br>20% discount if registering one month before event cost<br>10% discount for multiple registrations."]
Text[11]=["A Team-based Approach to Quality:<br>ensuring conformity to business processes","Why Should Quality Take the Lead on Collaboration?<br><br>Achieving compliance to business processes and regulatory requirements can take a toll on an organization. Burdensome quality procedures, although essential, can result in frustration and even hostility toward regulations and the quality personnel who are charged with enforcing them.<br><br>In this one-hour free webinar, we'll discuss the importance of coordinating calibration, maintenance and validation activity, why Quality may have the most to gain from this collaboration and how Blue Mountain Regulatory Asset Manager can simplify compliance to regulatory requirements.<br><br>Duration: 1 hour<br>Cost: Free"]
Text[12]=["Implementing an Enterprise Application at a Life Science Company","Because of regulatory requirements, software implementations in the life science industries are not straight forward.  This free webinar discusses what all is involved in an implementation and ways to cope with the process.<br>Duration: 1 hour<br>Cost: Free"]
Text[13]=["Calibration Manager 4 Training","This five-day course is designed to provide the knowledge needed to begin using and administering Calibration Manager 4.<br>Duration: 5 days<br>Cost: $2490"]
Text[14]=["Crystal Reports for Calibration Manager 4 Training","This two-day course focuses on modifying existing reports and developing new custom reports for Calibration Manager using Crystal Reports.<br>Duration: 2 days<br>Cost: $995"]
Text[15]=["Calibration Manager 4 - Calibration Histories and Reverse Traceability","This 2-hour web training provides in-depth instruction on how to record calibration histories in Calibration Manager and perform Reverse Traceability on standards when a problem arises.<br>Duration: 2 hours<br>Cost: $295"]
Text[16]=["Calibration Manager 4 - Measurement Data Collection and MD Templates","This 2-hour web training demonstrates how to collect measurement data within Calibration Manager, including instruction on the use of Measurement Data Templates to simplify entry for recurring calibrations.<br>Duration: 2 hours<br>Cost: $295"]
Text[17]=["Calibration Manager 4 - Electronic Signatures and Business Processes","This 2-hour web training demonstrates how to set up and use electronic signatures within Calibration Manager to ensure proper documentation and follow business processes.<br>Duration: 2 hours<br>Cost: $295"]
Text[18]=["Calibration Manager 4 - Key Performance Indicators","This 2-hour web training explains how existing and custom reports within Calibration Manager can be used to analyze trends and key performance indicators to uncover areas for productivity improvement.<br>Duration: 2 hours<br>Cost: $295"]
Text[19]=["Regulatory Asset Management 2007","This day long event combines presentations on calibration, maintenance and validation best practices with discussions of collaborative asset management, case studies and product demonstrations.<br>Duration: 1 day<br>Cost: $195"]
Text[20]=["Regulatory Asset Management Seminar","This half-day morning session features a presentation of the driving forces behind harmonization of calibration, maintenance and validation topped off with a demonstration of Blue Mountain Regulatory Asset Manager<br>Duration: 3 hours<br>Cost: Free"]
Text[21]=["NCSL 2007","NCSL is the premier event for the calibration discpline.  Blue Mountain will be exhibiting at the show and presenting 'Correcting OOT and Failure Escalation'."]
Text[22]=["Introduction to Life Science Calibrations","This 2-day regional training is designed for people new to calibration or who need to have a good understanding of the principles of calibration.  The training provides a firm understanding of the FDA requirements for calibration.<br>Duration: 2 days<br>Instructor: Marcus McNeely<br>Cost: $1500<br><br>20% discount if registering one month before event cost<br>10% discount for multiple registrations."]
Text[23]=["Life Science Calibration Best Practices","This 2-day regional training provides an in-depth treatment of calibration in life sciences, including the industry's best practices, and assumes a basic understanding of the principles of calibration.  Although there is some overlap, for a quick jump start into calibration, this course in combination with the Introduction course is a practical option.<br>Duration: 2 days<br>Instructor: Marcus McNeely<br>Cost: $1500<br><br>20% discount if registering one month before event cost<br>10% discount for multiple registrations.<br><br><strong>Includes free registration to Regulatory Asset Management Conference on October 17 at same location.</strong>"]
Text[24]=["Introduction to Biotech Calibrations","This 2-day regional training is a spin-off of the 'Introduction to Life Science Calibrations' course with examples specific to the biotech industry.  It is designed for people new to calibration or who need to have a good understanding of the principles of calibration.  The training provides a firm understanding of the FDA requirements for calibration and the best pracices for satisfying them.<br>Duration: 2 days<br>Cost: $1500<br><br>20% discount if registering one month before event cost<br>10% discount for multiple registrations.<br><br><strong>Includes free registration to Regulatory Asset Management Conference on October 17 at same location.</strong>"]
Text[25]=["Web demonstration of Blue Mountain Regulatory Asset Manager","This 1-hour web demonstration of Blue Mountain Regulatory Asset Manager provides insight into what makes this software unique and a high-level view of the collaboration between calibration, maintenance and validation within the software.<br>Duration: 1 hour<br>Cost: Free"]
Text[26]=["A Comprehensive Approach to the Facilities and Equipment Subsystem of QSIT","This 1-hour webinar is presented through the Institute of Validation Technology.  This presentation will discuss the different system options for a comprehensive approach to the Facilities and Equipment Subsystem of QSIT and provide some guidance on how to choose the option that is most appropriate for each company.<br><br>Topics include:<ul><li>What the FDA considers part of the Facilities and Equipment Subsystem of QSIT</li><li>Other driving forces behind a comprehensive approach for calibration, maintenance and validation</li><li>Differences and similarities between these Facilities and Equipment disciplines</li><li>Pro/Con analysis of the different system options available to companies today</li></ul><br>Register for the event through the Institute of Validation and Technology website"]
Text[27]=["A Comprehensive Approach to the Facilities and Equipment Subsystem of QSIT","This topic will be presented the Pharmatex Conference in Cork, Ireland.  We will discuss the different system options for a comprehensive approach to the Facilities and Equipment Subsystem of QSIT and provide some guidance on how to choose the option that is most appropriate for each company.<br><br>Topics include:<ul><li>What the FDA considers part of the Facilities and Equipment Subsystem of QSIT</li><li>Other driving forces behind a comprehensive approach for calibration, maintenance and validation</li><li>Differences and similarities between these Facilities and Equipment disciplines</li><li>Pro/Con analysis of the different system options available to companies today</li></ul><br>Click on title to view Pharmatex website."]
Text[28]=["Open House","An open house in the afternoon to meet with your International Sales Manager, David McClelland and pick the brain of our industry expert, Marcus McNeely.<br>Cost: Free"]
Text[101]=["Regulatory Assest Management: Harmonizing Calibration, Maintenance and Validation","Calibration, maintenance and validation activity, despite operating within the same department in some organizations, have generally been managed separately, each with their own procedures and their own computerized management systems. Since even calibration and maintenance professionals tend to access records differently and track different types of information, these separate and unconnected systems made sense. However with new regulatory pressures and in search of greater productivity and efficiency, leaders in the life science industries have explored and experimented with different ways to harmonize these systems. Until recently, the available options have required significant compromises to be made. This paper discusses the evolution of the driving forces and the available solutions for harmonizing calibration, maintenance and validation, concluding with the latest technologies designed to eliminate the need for the departmental compromises previously required to achieve harmonization."]
Text[102]=["CCMS Best Practices: making the most of limited calibration resources","This paper explores the calibration management system features and functionality common to best-in-class calibration management applications designed for life sciences. These features are demanded and used by some of the world’s most successful pharmaceutical, biotech and medical device companies and are intended to improve productivity and lower the costs and risks associated with compliance. Why are they so important to these companies? What are their benefits? How can you justify the time and energy required to learn to use these features and implement them?"]
Text[103]=["When to Upgrade: Balancing Benefits of New Systems with Costs to Upgrade","Not sure when to upgrade to new technology and software? Having difficulty convincing others that the time is now? This white paper examines the following, primarily for life science companies:</p><ul><li>The regulatory pressures that promote and discourage upgrading</li><li>The features in new systems that reduce risk and improve</li><li>Ways to reduce costs and risks associated with implementing and validating a new system</li><li>Guidelines for weighing the benefits versus the costs of upgrading</li><li>Examples specific to calibration and maintenance management systems"]
Text[104]=["Improving Employee Performance and Compliance in the Life Science Industries","Well-trained and resourceful employees are a well-known key to success for any company. Additionally, as demonstrated by some recent consent decrees, the FDA and other regulatory bodies have certain expectations about the level of training and demonstrated ability of key personnel at life science companies. Attention to employees, including their quality of performance skills and their diligence to compliance issues should warrant a place of importance in the company culture."]
Text[105]=["Minimizing Calibration Risk in Complex Biotech Environments","The importance of careful calibration management is made evident by the nature of risks that derive from poor calibration management, including scientific, regulatory and ultimately business risk. The biotech industry's risks in each of these cases are unique. Understanding these risks, the unique complexities of the biotech industries, and the strategies and tools available to reduce those risks, is important in minimizing and controlling those risks and their associated costs."]
Text[106]=["GMP Calibration Software Implementations: Containing Costs and Managing Risk","<p>As expectations from and complexity of management software implementations increase, many leading regulated Life Science manufacturers have chosen to some or all of these implementations. The issues propelling this decision include:</p><ul><li>Increased expectations to reduce risk and contain costs</li><li>Desire to achieve the full productivity benefits offered by calibration management software</li><li>More thorough system life cycle regulation by the FDA</li><li>More stringent validation requirements</li><li>Greater pressure on time and personnel limitations</li><li>More sophisticated systems requiring more varied expertise</li></ul>"]
Text[107]=["Validation of a Calibration Management Software System","It is prudent to select a validation process that produces the highest level of compliance with the minimum of resources. This paper identifies 3 key aspects to implementing & validating a CMS system. The basic aspects identified in this paper are based on Blue Mountain Quality Resources’ experience in implementing over 1,000 FDA calibration management software systems. The first two aspects, the User Requirements Specifications and Software Vendor Qualification provide the ground work for the third aspect, the Validation."]
Text[108]=["Architectural Benefits of Distributed Enterprise Calibration Management Systems","The Calibration Management System (CMS) must serve as a central hub between management, corporate metrology labs, corporate QA and the calibration sites. Just being connected is not enough. Interconnectivity and interoperability must be seamless and security controls must be precise enough to allow access to only the exact bits of data necessary, whether you are connecting to the system via LAN, WAN, VPN or the Internet, and regardless of your choice of platform. Whether you are working from a desktop, laptop or palmtop system, the CMS must be a seamless extension of the way you work."]
Text[109]=["Application of Electronic Records & Signatures in Calibration Management Software","Effective August 20, 1997, the Food and Drug Administration (FDA) issued 21 CFR Part 11, setting forth criteria under which the agency will accept, under certain circumstances, electronic records and electronic signatures. Part 11 allows firms to take advantage of electronic technology, and to have electronic records considered equivalent to traditional paper records."]
Text[110]=["Calibration Manager and 21 CFR Part 11","Migrating to 21 CFR Part 11 requirements has become a priority for many FDA regulated companies. This is no longer a concept for many of them, but rather tangible guidelines to be implemented into daily processes. This paper contains information on the ruling, as well as how Calibration Manager, the standard in calibration management software for FDA regulated software, meets the requirements of 21 CFR Part 11."]
Text[111]=["Asset Management for Growing Biotech Companies","As biotech companies grow, either as treatments progress through the development and marketing process or through success of a marketed product requiring new production capacity, they face unique challenges and opportunities in all areas, including asset management. The volume of instrumentation increases and new regulations for the management of assets apply at more advanced phases. To meet the complex demands involved in maintaining and managing the validated state of equipment and processes, a single unified approach to calibration, maintenance and validation makes the most sense."]
Text[112]=["Establishing Global GMP Compliance with an Enterprise Calibration Management System","Driven by tough FDA enforcement, attention to GMP compliance is at an all time high. In addition to having the responsibility for complying with increasing regulatory requirements, pharmaceutical manufacturers must find ways to improve their productivity. As a result of mergers and acquisitions, worldwide markets, and the complex nature of the drug development, the need for cost-effective global compliance has never been more important."]
Text[113]=["Implementing a Calibration Management System at a Life Science Company","The FDA has detailed regulations for the implementation of systems in life sciences that should be understood and managed when considering new technology."]
Text[114]=["Calibration Management of Outsourced Calibrations","In today's fast paced biopharmaceutical manufacturing environment, speed to market is the hallmark catch phrase. Many companies are focusing only on the processes that add the most value and are outsourcing the rest. This focus on core competencies has some biotech companies reevaluating their calibration practices. Many are contracting more of that workload, from both laboratory and production facilities, to calibration service laboratories."]
Text[115]=["Top Trends in Calibration Management Software","Now that the manufacturing economy has begun to climb out of its downward cycle, companies are apt to act less cautiously. They’re beginning to consider forward-looking projects that were previously on hold and review outdated processes, specifically software technologies. State-of-the-art systems are a possibility now that resources are available for investment. One such resource, the calibration management system, brings together a number of the latest trends in calibration management technology, including: migrating to next-generation software, outsourcing calibrations, collecting field data, understanding new technologies, benefiting from an enterprise implementation, and standardizing within an organization."]

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