Lisa Stewart

Lisa Stewart

Lisa Stewart has over 20 years of experience in the pharmaceutical industry with an extensive background in quality and validations. As a certified auditor for ISO, she has performed gap assessments for global laboratories, manufacturers, and medical devices companies. She has extensive knowledge in the validation of oral solid dosage (OSD), aseptic, and packaging equipment in addition to computer systems validation. Lisa has been a Senior Quality Specialist with Alcami for four years with the primary role of reviewing and approving validation and qualification protocols across multiple sites. Lisa holds a Bachelor of Science degree from the University of South Carolina.

Recent Posts by Lisa Stewart:

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017.  Ultimately, the FDA recognized the massive undertaking of such a requirement and extended the deadline to November 26, 2018.

Alcami began implementing serialization in 2015 to achieve the aggressive timelines and develop the necessary documentation needed to meet compliance.

This case study shows how Alcami has successfully transferred clients into the new serialization program.

Topics: Regulatory Compliance Serialization Drug Product Case Study