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Process Validation Prerequisites 101 Developing a medical device is a lengthy process, and medical device companies must meet a predefined set of requirements to ensure successful process validation. This white paper provides some great information on satisfying regulatory requirements while also ensuring good business practice. Complete the short form to download Running a Marathon in Flip-Flops, Part 1: The Value of Incorporating Prerequisites into Process Validation Undertaking process validation involves a major commitment in terms of personnel, resources, time, and money. Performing prerequisite verifications can reduce the risk of making costly mistakes. Complete the short form to download Running a Marathon in Flip-Flops, Part 2: The Value of Incorporating Prerequisites into Equipment Qualification Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective. Complete the short form to download Buyer Beware! How to Develop a Practical (and Compliant) Vendor Qualification Program Responsible purchasing is a regulatory requirement for pharmaceutical and biopharmaceutical manufacturers. Purchasing decisions must be well informed and documented, or risk impacting product quality, regulatory compliance, company profits, and company reputation. This article presents a practical and compliant methodology for pharmaceutical and biopharmaceutical companies to qualify vendors and make well informed purchasing related decisions. Complete the short form to download Steps to Equipment Qualification Prerequisites can streamline the execution of equipment qualification to prevent potentially expensive delays in the verification process. Verifying prerequisites before qualification ensures a safe and smooth qualification process. A prerequisite in an equipment qualification is a documented verification intended to demonstrate that everything is in order prior to initiating the execution of the qualification section. This article reviews the necessary steps. Complete the short form to download Going Green in Medical Device Manufacturing While “going green” is a recent cliché, it is also a key factor to consider when developing a product or modifying a process. In today’s economic climate, the regulated product manufacturer needs to perform a thorough cost-benefits analysis before considering such a change. Complete the short form to download Value-Added Integrated Project Management This short essay explores how to effectively help life science companies navigate the challenges associated with product development. A highly integrated and qualified Project Management (PM) methodology can support the alignment and implementation of business objectives and improve the odds and reduce the risk of product commercialization success. Complete the short form to download Project Change Control Worksheet Project change control is an integrative part of successfully managing any project. AHSI's ready-to-use project change worksheet can be used to manage your change requests, to log approvals, and document project changes. Complete the short form to download Change Control Log Use this ready-made Excel template in conjunction with the worksheet above to document and control changes in an Excel spreadsheet. Complete the short form to download Action Item List for Managing Projects Use this handy excel template to keep track of your project's action items and planning results. Print the document or port it directly into your own Excel for a clean, simple, ready-to-use template. Complete the short form to download Training in the Virtual Environment Economic pressures make increased worker productivity imperative, and while additional training can help you achieve this increased productivity, highly constrained travel budgets keep many people out of the classroom. Collaborative training tools can be used to avoid travel and its costs, but effectively utilizing these tools creates new challenges. Learn the basics of how to train in a virtual environment, including 8 quick tips to increase interaction, effectiveness, and overall participant satisfaction. Complete the short form to download |
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