Life Science Leader

Life Science Leader
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Life Science Leader

 •  June 15

Drug Sales Reel Amid Probe Into Charities. This was the headline of Jonathan Rockoff’s June 12, 2017, Wall Street Journal article that points out how sales for two U.S. “blockbuster prostate-cancer drugs” (i.e., J&J’s Zytiga and Pfizer’s Xtandi) were down (i.e., 14 and 11 percent respectively) for the first quarter from a year previous. Apparently...

Life Science Leader

 •  April 5

Course Description: FDA requires equipment in the pharmaceutical and medical device industries to be qualified before scientists and engineers are trained on its operation and subsequent use. Qualification is important as it determines that the equipment functions as the vendor intended, and is capable of supporting the work being performed for a...

Life Science Leader

 •  March 17

Course Description: As a medical device firm, your quality management systems are under constant surveillance, threats, risk, and regulatory scrutiny. Simplifying those systems will streamline your operations AND compliance efforts, reducing risks and allowing for flexibility and growth. Complicating any effort to implement lean quality systems is...

Life Science Leader

 •  March 7

Course Description Computer Systems Validation (CSV) warning letters and overall enforcement action has increased significantly over the last five years. Particular focus on CSV has occurred, in part, due to the growing number of clinical trials and increase in data generation streams. Enforcement actions have resulted in longer regulatory approval...

Life Science Leader

 •  March 7

Course Description: The world of cleaning validation is undergoing a significant transformation related to how product and cleaning agent carryover limits are calculated. The European Medicines Agency in their 2014, “Guideline on setting health based exposure limits,” is requiring the use of toxicologically derived limits for determining carryover....

Life Science Leader

 •  February 3

Training Session 2: The first session of this three-part Clinical Regulatory Document Management Compliance Professional (CRDMCP) certificate program will cover the regulatory requirements for the use of Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD), plus implementation best practices and global...

Life Science Leader

 •  January 27

Course Description: Effective communication with FDA is critical in successfully bringing any therapeutic product to market. However, communication includes much more than the written regulatory submission. Effective communication with FDA in all its forms must be concise, carefully considered, and reviewed to achieve the desired outcome. One must...

Life Science Leader

 •  January 22

Course Description: Expansions and renovations to existing biological facilities – and construction of new facilities – provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will reduce costs and improve compliance. This webinar will discuss how single-use systems are changing the...

Life Science Leader

 •  January 22

Course Description: The pharmaceutical business has a global shortage of aseptic fill sites and flexible biological manufacturing plants. This is primarily due to the decade-long mergers/acquisitions and consolidations in industry, driven by the financial pressures. This has forced facilities to produce and perform well beyond their anticipated...

Life Science Leader

 •  January 9

Course Description: Standard operating procedures (SOPs) are a fact of life in regulated industry. They are a critical part of almost every aspect of product production in the life sciences, and are therefore some of the most heavily scrutinized documents during regulatory audits and inspections. In fact, most FDA enforcement actions center around...