Andrew Campbell

Specialties: Management, Regulatory, Stability

 

Andrew Campbell has 33 years of multi-disciplinary Quality Assurance experience in support of commercial and clinical operations. His areas of expertise include CMO Qualification & Oversight, FDA and EMA Inspection Readiness, Stability Programs, Deviation-CAPA Programs, OOS Investigations, Change Control, Auditing, Training, Labeling, and Product Complaints.  Andrew has experience with various dosage forms including various dosage forms including parenterals, tablets, capsules, and suspensions.  He is equally familiar with direct manufacturing and outsourcing business models.

Working with large and small companies, Andrew has successfully developed, remediated, and implemented Quality Systems.  He has also provided FDA inspection support for several companies, including readiness training, on-site assistance during inspections, and authoring of written responses to inspectional observations.  Andrew is a skilled GMP Auditor, and has audited many API, drug product, packaging, laboratory, and distribution facilities.  He is also an experienced GMP Trainer and has developed customized training presentations on a wide variety of cGMP topics.

Prior to becoming a consultant in 2007, Mr. Campbell worked for Ligand Pharmaceuticals as Director of Quality Systems.  He received his B.S. in Chemistry from the University of California, Davis.
Courses:

    Implementing an FDA Compliant Stability Program