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West St. Pete and Clearwater employees attended the 3rd annual WWAR Gala night. It was a night to honor the men and women who have served our country.
The Wounded Warrior Abilities Ranch’s mission is to inspire veterans of all conflicts to get out and be active. The Ranch, which will be built at Lurie Park, will provide activities for all Military Veterans in need of support and healing. A purpose-built park, the Ranch will have a wide variety of activities available to Wounded Warriors, Veterans, and their caregivers.
St. Pete has been involved with this organization since 2015 as part of the “Year of the Military” fundraising campaign. Our partnership includes an annual West vs WWAR softball game and over 200 hours of volunteer time.
This year we were honored to be one of the 4-Star General Sponsors for the gala. Both St. Pete and Clearwater employees attended the dinner and helped raise money to complete the Ranch.
Giving back to those that served our country is near and dear to the St Pete employees; we currently have 30 employee veterans. Please visit the Our Culture of Giving section of our website to read more about West’s giving.
When evaluating the vial system for your drug product, how do you know you’re making good decisions about protecting the drug product while also meeting regulatory expectations for data requirements as outlined in ICH Q9? To illustrate how complex it is to determine how much data is enough to make good, sound, decisions on your vial containment system, two 20mm container closure systems (CCS) were evaluated with the primary difference being the hardness of the rubber vial stopper. The designs were identical for each stopper, meaning the specifications, nominal dimensions, and other major features were the same.
On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (<em>Elemental Impurities – Limits</em>) and USP <233> (<em>Elemental Impurities – Procedures</em>) have replaced USP <231> (<em>Heavy Metals</em>). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (<em>Elastomeric Closure for Injections</em>), which is used for testing of elastomeric closures, still references USP <231>.
Beyond the challenges of ensuring that data privacy laws are observed across the globe, West IT is faced with the need to safeguard intellectual property, trade secrets, and confidential company and employee data while ensuring that we can serve our global customers. This is becoming increasingly more complex with the rapid advances in mobility and cloud computing. At West, IT is evaluating the best way to enable our employees to take advantage of these rapid advances in technology while still ensuring protection for confidential company information.
Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.
The health and safety of our team members has always been West’s top priority. This mindset is supported by our Board of Directors and is led by our President and CEO, Eric Green, who often reiterates his belief that “one incident is one too many.”
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