Lead Quality

The ISO 9000 series of standards has been used for illustrative purposes throughout this book. However, all the leading Quality Management systems have similar structures so you will find the concepts familiar regardless of which system your company has adopted. Chapter 9 summarizes the principal differences and similarities between ISO 9000 and other commonly used Quality Management systems. 

Potency alone is a poor predictor of lead quality ligand efficiency... 

The logical dissection of the various possibilities wiU, by application of the guiding idea of GLP, provide the unambiguous answers. The Lead Quality Assurance unit has to judge and attest to the overall GLP compliance of the study. If this Lead Quality Assurance cannot perform the necessary inspections itself, then it has to rely, for this judgement to be rendered, on the reports and statements of any secondary Quality Assurance, irrespective of whether this secondary Quality Assurance were employed by the same... 

While the physical cost of implementation was small (a few fax machines, some recovered shelving, cards, etc.) and the nonphysical cost reasonable (training, outside guidance, etc.), the returns are impressive. In addition, this approach opened the way for other such approaches in other parts of the business, which has been formally recognized as a leading quality supplier in this very competitive industry. 

Black Belt (BB) employees trained in Six Sigma whose main purpose is to lead quality projects and work full time until they are complete. Black Belts can typically complete four to six projects per year with savings of approximately 230,000 per project. 

Plan Source Make Deliver Return (S) Return (D) KPI Description Lean- Lean- Lean-lead quality cost time Agile- Agile-lead quality time Agile- flexibility Suitable corrective actions in case of insufficient performance (Phase 3)... 

Lean- Lean- Lean-lead quality cost time... 

Agile- Agile- Agile- Suitable lead quality flexibility corrective time actions in case... 

Figure 2.1 When the LG puzzle does not fit together, quite often there are multiple factors involved, and time pressure to deliver quickly can be detrimental to lead quality.

Predicted Dose to Man as a Measure of Early- and Late-Stage Lead Quality 467... 

Predicted Dose to Man as a Measure of Early- and Late-Stage Lead Quality 1473 Table 16 eD2M (mg) versus Cmin normalized dinical dose (mg) for 22 AZ CDs. 

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