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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 firstname.lastname@example.org