total approach to pharmaceutical process validation

Ngày tải lên: 22/12/2013, 02:17

... Clayton Road, Clayton, Melbourne, Australia 4University of Toronto, Department of Surgery, College Street, Toronto, Canada 5Southern Health Quality Unit, Monash Medical Centre Clayton Clayton ... included to ensure that the knowledge and its subsequent implementation are relevant to their needs [25] Once the scope and barriers to the RRS are understood, we will pilot a redesign of the RRS to ... insight into why clinical staff fail to call for help when it is needed, and what cognitive or socio-cultural factors are the overriding factors in this Identification of the barriers to calling...

Ngày tải lên: 10/08/2014, 10:23

... been the only factor They conclude that, to be successful, implementation processes would have to include system changes, such as the integration of DSTs into an informed consent process, or incentives ... requirements (where shared decision processes are assumed to be quality indicators), or reimbursement to professionals who make shared decision programs available to patients Gravel and Légaré's ... an explanatory framework We wish to proceed to work that can test whether the model can also be predictive, although we are cautious about claiming power to foresee the outcome of processes characterized...

Ngày tải lên: 11/08/2014, 16:21

... powerful video-editing tools Then share your story everywhere, from YouTube to Blu-ray and everything in between VideoStudio Pro now includes DVD Factory Pro integrated DVD and Blu-ray ... Blu-ray to the Web Enhanced! Upload directly to YouTube, Vimeo, Facebook and Flickr® Now also in HD! Burn CDs, DVDs, Blu-ray and AVCHD discs New! Burn HD video to standard DVD media to play on ... RevoStock templates Express movie making – create movies in minutes, then fine-tune with advanced editing tools Real-time effects – work fast with live previews of special effects like RotoSketch...

Ngày tải lên: 27/08/2012, 11:20

... 2001) Process Identification n n n Each process, or independently scheduled execution context, has its own process descriptor Process descriptor addresses are used to identify processes n Process ... optimizations CS591 (Spring 2001) The switch _to Macro n n switch _to( ) performs a process switch from the prev process (descriptor) to the next process (descriptor) switch _to is invoked by schedule() & is ... memory area is allocated for each process, to hold process descriptor and kernel mode process stack n Advantage: Process descriptor pointer of current (running) process can be accessed quickly...

Ngày tải lên: 12/09/2012, 14:40

... khía cạnh động qui trình n n Chu kỳ (cycles), pha (phases), trình lặp (interations), cột mốc (milestones) Trục tung : tổ chức theo nội dung công việc, thể khía cạnh tónh qui trình n WHO (worker),...

Ngày tải lên: 12/09/2012, 15:04

... Report ? Guidelines, tool mentors templates giúp dễ dàng ứng dụng qui trình đắn quán Gi?i thi?u v? Rational Unified Process Duong Anh Ð?c, 2001 35 Tool hỗ trợ to n chu kỳ sống PM Process Workflows ... Rational Unified Process Duong Anh Ð?c, 2001 34 Guidelines, Mentors, Templates ? Guidelines luật, gợi ý, heuristics hỗ trợ cho hoạt động ? dụ, modeling programming guidelines Ví ? Tool mentors diễn ... fill the code Openning add( ) delete( ) close file Actor A Actor B close file Reading Use-Case File Repository (from Persistence) Customer name addr receive() withdraw() fetch() send()...

Ngày tải lên: 12/09/2012, 15:04

... meeting Chairman or moderator Manages the process and facilitates the inspection Reports process results to the Chief moderator Chief moderator Responsible for inspection process improvements, checklist ... than other approaches There were fewer errors than in a 'traditional' development process However, the process is not widely used It is not clear how this approach can be transferred to an environment ... Static analysers are software tools for source text processing They parse the program text and try to discover potentially erroneous conditions and bring these to the attention of the V & V team...

Ngày tải lên: 14/09/2012, 11:41

... of failure are high so it is cheaper to find and remove faults than to pay for system failure; You may have to make a formal case to customers or to a regulator that the system meets its dependability ... the total system development costs ©Ian Sommerville 2004 Software Engineering, 7th edition Chapter 24 Slide Reliability validation    Reliability validation involves exercising the program to ... through their analysis to the actions taken during the process to ensure that these hazards have been covered A hazard log may be used to track hazards throughout the process    ©Ian Sommerville...

Ngày tải lên: 14/09/2012, 11:41

... used to identify process tool support The process improvement cycle involves process measurement, process analysis and process change Process measurement should be used to answer specific process ... Informal process Mana ged process Configur ation mana gement tools Generic tools ©Ian Sommerville 2004 Methodical process Project mana gement tools Analysis and design wor kbenches Impr o ving process ... defined process standards this is very difficult as you don’t know what to measure A process may have to be defined before any measurement is possible Process measurements should be used to assess process...

Ngày tải lên: 14/09/2012, 11:41

... Detailed processes to ensure that a logical model contains adequate content to lead to a successful physical model is one such process • Environmental input (requirements) can only be taken into consideration ... Limited cookbook approach Training prior to project Medium low At end of each iteration Limited cookbook approach Training prior to project Medium Limited cookbook approach Training prior to project ... that the systems development process is empirical: Applicable first principles are not present The process is only beginning to be understood The process is complex The process is changing 20 Most...

Ngày tải lên: 17/09/2012, 10:03

... Table Extent of PO ] at different acid to m u d ratios For OPh-solutions (C o = 46 rag/l) For TPPh-solutions (Co = 28 mg/l) Acid to m u d ratio, ml/g E, % Acid to m u d ratio, ml/g E, % 10 15 20 ... varied from to 24 h at continuous mixing using a magnet stirrer The treated mud was separated from the acid suspension, washed with distilled water (to pH 7), dried at 105°C and ground to powder ... Couillard, D., 1982 Use of red mud, a residue of alumina production by the Bayer process in water treatment Sci Total Environ., 25:181 191 [4] Couillard, D., 1983 Phosphorus removal from waters...

Ngày tải lên: 23/09/2012, 14:47

... suffice to define, in a probabilistic sense, the range of amplitudes which the random process displays To gain a sense of how quickly varying the members of the ensemble are likely to be, one has to ... random process has a finite power density spectrum, it may be expected to approach a gaussian process as a result of low-pass linear filtering Unfortunately, it does not seem possible to phrase ... and Thus all the statistics of a gaussian process are defined by the autocorrelation function for the process This property is clearly a great boon to analytic operations LINEAR SYSTEMS The input-output...

Ngày tải lên: 15/10/2012, 15:43

... it is asymptotically so if |a| < S τ τ LECTURE STOCHASTIC PROCESSES The AR process easily generalizes to an order p Xt + a1 Xt−1 + · · · + ap Xt−p = t Let z denote the unit delay operator Then ... an AR(p) process is equivalent to an infinite order MA process, and vice versa Mixed AR + MA processes, called ARMA processes are also in existence Spectral estimators exist which are based on ... ORDER AUTOREGRESSIVE PROCESS where a is a constant and { t } is random This is analogous to linear regression with Xt depending linearly on Xt−1 and being the residual, hence the term t “autoregressive”...

Ngày tải lên: 15/10/2012, 15:43

... it is asymptotically so if |a| < S τ τ LECTURE STOCHASTIC PROCESSES The AR process easily generalizes to an order p Xt + a1 Xt−1 + · · · + ap Xt−p = t Let z denote the unit delay operator Then ... an AR(p) process is equivalent to an infinite order MA process, and vice versa Mixed AR + MA processes, called ARMA processes are also in existence Spectral estimators exist which are based on ... ORDER AUTOREGRESSIVE PROCESS where a is a constant and { t } is random This is analogous to linear regression with Xt depending linearly on Xt−1 and being the residual, hence the term t “autoregressive”...

Ngày tải lên: 16/10/2012, 09:09

... well as its subsidies to favored private sector borrowers In our example, real sector investment declines in spite of government subsidies to the private sector Total real sector assets decline ... Assets ∆ Total Assets Total Liabilities & Net Worth The fundamental decisions that influence economic performance – how much to consume and save; how to allocate the flow of savings; and how to allocate ... valuable option to investors Even if the investor does not plan to sell the primary claim before maturity, the investor’s future portfolio allocation preferences are inevitably subject to uncertainty...

Ngày tải lên: 24/10/2012, 09:40