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onlinecompliancepanel Press releases

11 - 20 of 28 Press Releases

Jan 07, 2013
Clearly written, detailed Standard Operating Procedures (SOPs) are one of the key indicators of the caliber of regulatory compliance enforced by an organization.

Jan 07, 2013
Regulatory agencies have stepped up audits to aggressively enforce computer systems validation (CSV) and CFR 21 Part 11/Annex 11 implementation.

Jan 07, 2013
This is a course that anyone in a hospital or clinic who might be involved in conducting a clinical trial should take.

Jan 07, 2013
Computer Validation is required by the GMP regulations and FDA has posted a Guidance Document on Electronic Signatures.

Dec 11, 2012
The medical device industry is characterized and mandated by compliances with government regulations. And, failure to adhere to stated stipulations lead to severe civil and legal liabilities.

Oct 01, 2012
The clinical trial protocol is a multi-dimensional document that plays a critical role in the success of a clinical trial.

Oct 01, 2012
Class participants will familiarize themselves with the federal laws and regulations enforced by DEA pertaining to Schedules II though V controlled substances that is dispensed, or prescribed by a physician as part of a pain treatment plan.

Sep 19, 2012
A 505(b)2) product is an improved or altered version or a new use application for a previously FDA-approved drug.

Sep 19, 2012
A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices.

Aug 29, 2012
This presentation talk about the extensive amount of information provided on the DEA regulation requirements for any pharmacy or pharmacist for controlled substances that are purchased and dispensed in a form of a prescription.

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