Email comments to: [email protected](Subject: "Comments on Draft SP 800-56A Rev. SP 800-56C has been revised to include all key derivation methods currently included in SP 800-56A and SP 800-56B, , in addition to the two-step key-derivation procedure currently specified in SP 800-56C.3")Comments due by: November 6, 2017NIST announces the public comment release of SP 800-56C Rev. Note the change of title for SP 800-56C that reflects the inclusion of the additional key-derivation methods.Email comments to: [email protected](Subject: "Comments on SP 800-70")Comments due by: August 30, 2017.Twelve 2-day In-person Interactive GMP and Validation seminars available in America, Europe and Asia delivered by Dr. Risk Based Validation of Computer Systems and Part 11 Compliance With Strategies for FDA/EU Compliance and Tool Kits for effective implementation March 4, 2015 Risk-based compliance is expected by regulatory agencies and strongly recommended by industry task forces and private authors to balance compliance efforts and costs vs. Risk management has a long history in the industry.
EVMTech’s operational risk advisory team supports financial institutions with development of Basel II and Solvency II compliant operational risk management and measurement frameworks. Our extensive experience combined with our know-how and research makes us a unique partner in developing proven and industry-leading solutions.
Risk management is the process that helps to identify problems, analyze them and then to create an action plan to avoid or manage these problems.
The objective of risk management during pharmaceutical device and drug development and manufacturing is to provide drugs and devices that are efficient and safe without spending too many resources, for example, for validating processes and equipment.
Risk assessment is also nothing new in our private life.
We experience this every day long before we start our daily work.