1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
6B526C563CA11D2AD85257EBC006CC604
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/db-benchmarking-biopharma-quality-capa-processes-quality-staffing-outsourcing-trends?opendocument
18
19opendocument
2018.204.48.40
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25DB




» Products & Services » » Quality, Compliance and Regulatory » Structure,Staffing and Execution

Benchmarking BioPharma Quality and CAPA Processes: Quality Staffing and Outsourcing Trends

ID: 5379


Features:

8 Info Graphics

9 Data Graphics

60 Metrics

1 Narratives


Pages/Slides: 27


Published: 2015


Delivery Format: Online PDF Document


 

License Options:
close

Single User: Authorizes use by the person who places the order or for whom the order was placed.

Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.

Corporate: Authorizes use for the entire company for a year and copies can be printed. No limitations for usage inside the company.




Buy Now

 


  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from "Benchmarking BioPharma Quality and CAPA Processes: Quality Staffing and Outsourcing Trends"


STUDY OVERVIEW

Biopharmaceutical companies invest heavily to ensure their products meet Quality standards.

But as costs rise, Quality leaders face a constant struggle to balance quality and safety with costs and risk. Ironically, Quality staff play a big role in both - they are a cost driver and a quality enforcer. Maintaining the appropriate mix of Quality staff is therefore important to both safety and cost.

Research and consulting leader Best Practices, LLC undertook a new study that reviews current Quality staffing levels for biopharmaceutical companies, including total Quality staff, Quality staff per $100 million in revenue and Quality staff as a percent of total staff. The study also has insights on the advantages and risks of outsourcing Quality roles.

Quality leaders can use this research to compare their Quality staffing levels with their peers.

This study presents two segments on some questions: All Participants and Large Companies

KEY TOPICS

  • Quality Staff Levels
  • Outsourcing Quality
  • Best Practices for a Robust Quality Function

SAMPLE KEY METRICS
  • Total number of FTEs in Quality function
  • Quality FTEs per $100 million in revenues
  • Quality FTEs as a percentage of total FTEs
  • Percentage of Quality activities does in-house versus outsourced
  • Percentage of Quality in-house activities done in established markets versus low wage markets

SAMPLE KEY FINDING
  • Outsourcing Quality: In order to build successful outsourcing capabilities, companies must understand how to manage risks associated with outsourcing processes. A majority of the benchmark class (>85%) manages quality activities in-house for the 7 activities that were evaluated in the study.
METHODOLOGY

Best Practices, LLC recruited Quality function and CAPA Process executives at 14 biopharmaceutical organizations to share their data and insights in a customized benchmarking study.

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


Companies Profiled:
Roche; Biogen; Amgen; Baxalta; UCB Pharma; AstraZeneca; Genzyme; Eisai; GlaxoSmithKline ; United Therapeutics; RIEMSER Pharma; ohm Laboratories; Valeant; Douglas Pharmaceuticals

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.