Top Pharmacies in Fremont, CA 94539
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GlobalCompliancePanel.
By Anonymous July 31, 2014
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings for Pharma, Medical, Regulatory, Compliance, FDA ext. Professionals. ...read more
CVS Pharmacy
By zreality at Citysearch June 07, 2010
Along with the every day deals in the store, CVS Pharmacy has proven to be a real resource and convenience for me. The store was changed from Longs to CVS a while ago. I don't know what everyone else thinks, but I like the change.\t\nOne of the things that did not change was the Longs to CVS Pharmacy staff. Great decision. These professionals were great when it was Longs and they are still great!\t\nThe folks at CVS Pharmacy have gone above and beyond for me. They sorted out some difficulties with my prescriptions in very short order. I am so very grateful to them for their excellent work.\t\n ...read more
Rite Aid - Closed
By shilpa v. at Judy'sBook April 10, 2006
I am not sure why, but I always preferred walgreens to rite-aid before. I think because the layout of walgreens flyer is very clean and that of rite-aid is hard to read, I probably didn't visit rite-aid so much. But now I go there often. Th... ...read more
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Applied Statistics for FDA Process Validation
GlobalCompliancePanelhave been successfully organized the 2 days seminar in Philadelphia, PA from May 17th & 18th, 2018 by NetZealous LLC. The Food and Drug Administration (FDA) provided a guidance for industry in 2011 that has established a framework for process validation in the pharmaceutical industry. This guidance, titled “Process Validation: General Principles and Practices” consists of a three-stage process. The three stages are 1) Process Design, 2) Process Qualification, and 3) Continued Process Verification. ...read more
By GlobalCompliancePanel. May 22, 2018
Meeting FDA Expectations on Supplier Audit Program
The FDA, being what it is; has enormous power over the working of a medical device’s supply chain. It can virtually intercept a medical device at almost any stage through its various mechanisms such as recalls, injunctions, seizures and others. In its enthusiasm to ensure higher quality for medical devices, it has sometimes gone overboard to the extent that it is now a highly mistaken and feared regulatory body. Making Supplier Audit Program comprehensible Taking note of this perception, the FDA has been working hard to appear softer. One of the regulatory changes it has made to enforce this thinking has been to clearly state the conditions for meeting its expectations on Supplier Audit Program. The logic for choosing to make changes into the Supplier Audit Program is simple –as we just saw; it does not want to be seen as being arbitrary in selecting and punishing companies during their supply trail. It has set out a number of regulations and directions aimed at making the Supplier Audit Program simple and understandable. Ask these questions to meet expectations As a result, if companies have to meet the FDA's expectations on Supplier Audit Program, they will need to ask themselves and answer questions such as: how do we address the FDA's stated desire to require "on-site" audit of all Pharma suppliers? What expectations does the FDA have for meaningful, results-driven actions that address and resolve any underlying compliance issues or product problems? How do we reevaluate our vendors and the methods used in selecting, evaluating, auditing, retaining or cutting adrift such regulatory "partners" if we have to meet the new regulatory climate and be competitive? References: http://www.enhancequality.com/auditing/supplier-audits/ http://www.sqaservices.com/Page.aspx/effective_audit_program http://www.eduquest.net/Supplier_Mgmt_Auditing_2012_Training_Class.htm For More Info Click Here: https://www.globalcompliancepanel.com/control/Blog ...read more
By GlobalCompliancePanel. July 31, 2014
FDA Compliance and Ethics
The FDA has, over the years of its growth, been enacting laws that seek to ensure that all aspects that it covers are ethical. The FDA has been aware of the need to formulate rules and laws governing ethics. In fact, its forerunner, the Pure Food and Drug Act, enacted in 1906, more than three decades before the FDA came into existence, had a provision on ethics. With the passage of time, even as the FDA's reach and power expanded, ethics was one area it never compromised on. Laws governing ethics went on getting strengthened as the FDA evolved. Successive years of research and effort have given place to a number of well-defined, clearly stated laws on ethics that have to be complied with. The result is that today, any clinical trial or a product that is a result of it will never get approved by the FDA unless it has passed the test of ethics standards prescribed by this regulatory body. Today, ethics laws are enacted to cover the following areas: Human Participation (Institutional Review Board or IRB):Formulated with the intention of ensuring that any institution or organization that carries out clinical research involving humans complies with FDA regulations; Animal Subjects (Institutional Animal Care&Use; Committee (IACUC):Tasked with overseeing the welfare of animals and ensuring that there is compliance with all aspects of rules governing clinical trials on animal subjects; Conflict of interests:The FDA lists out clear benchmarks by which its employees should comply when interacting with individuals or institutions or companies in which research is being carried out; Scientific misconduct:There are clearly defined parameters by which to ensure that scientists and other staff participating in research should comply with; Public access:To ensure that only designated staff get access to valuable scientific material; the FDA has regulation that state clearly the nature of disclosure to the public of records relating to medical research. How does the FDA ensure compliance? The FDA ensures compliance with set ethics regulations by carrying out what are called Ethics Committee Inspections. It performs, on average, 200 such inspections a year on clinical research sites. Each inspection lasts two to five days. References: http://osp.ua.edu/site/PRCO_History.html http://osp.ua.edu/site/irb.html http://osp.ua.edu/site/iacuc.html http://osp.ua.edu/site/RC_CoI.html http://osp.ua.edu/site/RC_SM.html http://osp.ua.edu/NIH_policy.html http://www.ich.org/fileadmin/Public_Web_Site/Training/GCG_-_Endorsed_Training_Events/APEC_LSIF_FDA_prelim_workshop_Bangkok__Thailand_May_08/Day_4/Inspection_of_Ethics_Committees_Lepay_FDA.pdf For More Info Click Here ...read more
By GlobalCompliancePanel. July 31, 2014