David is a Senior Quality Consultant with extensive experience in cGMP compliance of the manufacture of Pharmaceutical products. This includes solid dose, aerosol, dermatological, liquid and encapsulated product types.

David Shackelford

David is a Senior Consultant with extensive pharmaceutical Quality Assurance related experience. His areas of expertise include Process/Product Validation, Quality oversight of Contract Manufacturers and cGMP compliance related to CAPA implementation and many other areas of pharmaceutical manufacture.

David has over 33 years of experience in the pharmaceutical industry which includes two years in the GSK’s Compliance Audit Group (CAG) as Director of CAPA Verification, one year as Director of Verification and Improvement, two years as Strategic Quality Director in External Supply Quality, nine years as Quality Head/Strategic Quality Director managing staff and projects for contract manufactured product. In addition, one year as a Contract Quality Manager, fifteen years as supervisor of the Process Validation Department and three years as a Process Validation Specialist at GlaxoSmithKline (GSK).

Further experience as a chemist with North Carolina Department of Agriculture (NCDA) and GSK which included chemical analysis of pharmaceutical raw materials, finished product, agricultural feed and fertilizer samples.

David studied Chemistry at the University of North Carolina at Wilmington (UNCW). Postgraduate studies in Biochemistry was performed while working as a chemist for the North Carolina Department of Agriculture (NCDA).

Some of his more significant accomplishments include:

  • CAPA Verification process at multiple sites supporting site remediation
  • Supported the compliance requirement commitments made to the Office of Inspector General
  • Due Diligence audits of prospective contract manufacturers
  • Lead cross-functional multi-national validation remediation team
  • Lead multi-site cross-functional product transfer team