Pharma Quality Assurance Toolkit Bundle: Best Practices, Benchmarks and Case Studies for Pharmaceutical Program Excellence

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"Pharma Quality Assurance Toolkit Bundle: Best Practices, Benchmarks and Case Studies for Pharmaceutical Program Excellence"

As the cost and risk associated with Pharma R&D and drug launches rise, companies are faced with conflicting needs to reduce costs and ensure quality. Whether it be in the lab, clinical trials or a manufacturing facility, a lack of Quality Assurance can delay or destroy a successful drug launch.

Executives in the pharmaceutical industry who oversee Quality Control and Assurance are looking to the tools of benchmarking and best practices to find opportunities for savings and efficiency gains in the R&D function. Analysts at Best Practices, LLC have compiled a toolkit for improving R&D based on several recent studies with 10 of the top 20 pharma companies.

Included in the toolkit are the following research documents:

1. Quality Assurance Staffing and Use of Risk-Based Approach Programs (4884) - Identifies span of control for QA functions; staffing levels for GMP, GLP and GCP; activities in QA that are commonly outsourced; and an industry perspective on RBA programs in place.
2. Pharmaceutical Company Profiles of Using Risk-Based Approaches in Drug Development (4888) - details the status of RBA at six blinded major pharma companies, the QA tools used, the scoring system, risk parameters and the impact of RBA. Based on interviews with executives at each company.
3. Driving R&D Quality Excellence: Key Industry Challenges and Lessons Learned (4594) - details the top three Quality Assurance lessons learned and industry challenges at eight different pharma companies. Based on interviews with executives at each company.
4. Best Practices in R&D Quality Structure (4592) - details best practices in Quality Assurance based on organizational structure, buy-in programs and interaction with other company functions. Based on interviews with executives at eight companies.

For questions on the implementation of this toolkit, please contact us at (919) 403-0251 or email at best@best-in-class.com

Industries Profiled:
Pharmaceutical; Biotech; Health Care; Medical Device


Companies Profiled:
Sanofi-Aventis; Abbott Laboratories; Amgen; Boehringer-Ingelheim; Bristol-Myers Squibb; Cardinal Health; Eli Lilly; GlaxoSmithKline; Johnson & Johnson; Mayne; Medarex; Novartis

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.

This bundle combines all of the individual research listed below into one easy-to-purchase transaction. Read individual research abstracts by clicking the titles. Return to this page to add the bundle to your cart.

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Why purchase a bundle?
Purchasing this research together provides you with significant savings over the individual research price. In addition to the reduced price, you’ll also experience ease of use. After purchase, previous and next buttons will direct you sequentially through the research findings. If you have additional questions, please call us at (919) 403-0251.