Webinars

Live Webinars

October 11, 2016 2PM ET
Drexel Rothrauff - Director of Marketing

This webinar will show how you can leverage industry-standard GMP asset management software without large upfront capital expenditures, validation efforts or in-house IT resources. Purpose-built for Life Sciences, Blue Mountain RAM Cloud Essentials is the perfect solution for Biotech, Medical Device and Pharmaceutical companies looking to implement a best-in-class, out-of-the-box, SaaS (Software-as-a-Service) asset management application. The webinar will be followed by a live Q/A session.

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November 8, 2016 2PM ET
Ginny Lee – QA Coordinator

Adherence to CGMPs is vital to all Life Sciences manufacturers. Even with all of the recent discussion, it is important to understand that the recently published guidance, titled "Data Integrity and Compliance with CGMP," does not bring anything new to the table. This webinar emphasizes how the FDA’s “new” draft guidance is simply a clarification of the importance of data integrity to CGMP; enabling reliable, accurate data to produce safer products.

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Recorded Webinars

Adherence to CGMPs is vital to all Life Sciences manufacturers. Even with all of the recent discussion, it is important to understand that the recently published guidance, titled "Data Integrity and Compliance with CGMP," does not bring anything new to the table. This webinar emphasizes how the FDA’s “new” draft guidance is simply a clarification of the importance of data integrity to CGMP; enabling reliable, accurate data to produce safer products.

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In this webinar, we discuss the best practices for GMP asset management in new facilities with a special focus on the unique needs of Biotech companies. The webinar covers the importance of implementing an EAM/CMMS early on in a new facility, handling new and transferred equipment, driving process consistency and automation, managing records, validating software and strengthening FDA compliance.

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Enterprise-wide (or multisite) asset management software is in growing demand in the Life Sciences industry. Companies and management desire a corporate view of their facilities in order to drive efficiencies and to meet several new demands.

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Several significant industry trends are driving the adoption of mobile devices and paperless environments. With these trends, many companies are looking at what it takes to go paperless and what it means to go mobile in their facility.

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Contract Manufacturers create products for many customers, each with unique requirements. Their customers expect them to deliver the highest quality products while maintaining compliance, reducing costs and keeping tracking of equipment.

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In working with hundreds of customers throughout the year, we have seen the challenges impacting the Life Science Industry - the economy, FDA enforcement activity, patents, etc. Pharma, Biotech and Medical Device are having to find ways to make adjustments and do things better, faster and cheaper. The question is - what are those "ways" or "Best Practices"?

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It's hard to think that GMP enforcement could get any tougher, but we believe it will. This webinar provides an overview of the FDA's recent and projected strong enforcement activities including High Impact Warning Letters, 483's and Consent Decrees. We'll also touch on the unique compliance concerns of Medical Device, Biotech and Pharma companies. Finally, we'll discuss how these enforcement and compliance challenges affect a company's maintenance activities and procedures and they can help you build the case for greater investment in GMP systems.

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At a macro level, business spending is on the rise and companies are expected to put their excess cash to work during the second half of 2013. Expectations for the pharmaceutical industry include an uptick in M&A activity with companies focusing on new products/services, improving operational efficiency and expansion in current markets. This webinar will provide a broad overview of industry trends and specific discussion of how these trends can help you make the business case for increasing the budget for GMP systems.

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Join Jim Erickson, President of Blue Mountain, as he explores how to leverage EAM / CMMS applications to manage compliance risks. He will cover a range of information including recent FDA warning letters, cost of non-compliance and EAM / CMMS best practices.

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As corporations move toward implementations of major ERP (Enterprise Resource Planning) systems, resident calibration and maintenance modules are increasingly mandated, often without user acceptance. With corporate focus on efficiency of implementing a single solution, maintenance and calibration functionality falls short of specific user requirements.

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