PDA/FDA 2026 session maps the GMP audit lifecycle, root cause to CAPA closure, plus a local vs. above-site decision framework and two case studies.
News|Articles|October 15, 2020
- Pharmaceutical Technology-10-15-2020
- Volume 2020 eBook
- Issue 3
Strong Quality Culture: A How-To for Busy Managers
Author(s)Norm Howe
Building employee participation and forming good habits contribute to a company-wide quality culture that pays off.
Advertisement
Managing people—and establishing a culture that promotes quality, is challenging for scientists and engineers in the pharmaceutical industry who are accustomed to functions that can be measured. Managing and developing quality concepts that are not readily measured can be difficult.
A case study shows how embedding quality habits into employees helps them do a task right the first time by off-loading routine good manufacturing practices from their conscious to unconscious mind. The result can be the establishment of desirable quality habits for members of the organization.
Article Details
Pharmaceutical Technology
eBook: Regulatory Sourcebook
October 2020
Pages: 65–67
Citation
When referring to this article, please cite it as N. Howe, “Strong Quality Culture: A How-To for Busy Managers," Pharmaceutical Technology Regulatory Sourcebook eBook (October 2020).
Articles in this issue
almost 6 years ago
Enhancing Process Validation for Solid Oral Dosage Forms: Part 2almost 6 years ago
Due Diligence Assessment of CMC Activitiesalmost 6 years ago
Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?almost 6 years ago
Tackling Cybersecurity Challenges in Legacy Systemsalmost 6 years ago
Ending ‘Magical Thinking’ in Compoundingalmost 6 years ago
Viral Vector API Characterization of Product-Related Impuritiesalmost 6 years ago
Resources, Guidelines, and Guidance Documentsalmost 6 years ago
Regulatory and Standard Setting OrganizationsAdvertisement
Related to this article
Lori Dingledine, QC Director Microbiological Control and GTIC Operations at Genentech, provided input on the regulations surrounding raw material manufacturing and use for ATMPs in a presentation at the 2026 PDA/FDA Joint Regulatory Conference.
Karthik Iyer, Eli Lilly, details an AI system linking GMP findings, audits, and deviations for cited, inspection-ready regulatory intelligence.
At the PDA/FDA Joint Regulatory Conference 2026, Helen Motamen, MS
global head, Sanofi Quality Audit, Inspection, Intelligence & Advocacy, at Sanofi, provided advice for creating a strong internal audit program.
At PDA/FDA Joint Regulatory Conference 2026, PCI Pharma's Bassler details how a QMS overhaul turned an FDA 483 into stronger quality culture.
AI can turn medical device risk management into a continuous signal.
On PharmTech.com this week, coverage of upcoming events continued, experts continued to discuss the use of AI in pharma, and validation in oral solid dosage product production was emphasized.
This article explores the historical use of silicone oil in the performance of primary drug product packaging; design of experiment test results for selection of the cleaning agent and CCPs; assessment of visible residue limits and Fourier-transform infrared spectroscopy surface analysis; and setting health-based exposure limits for silicone oil using a non-uniform distribution model, and a previously published permitted daily exposure.
Advertisement
Advertisement
Trending on Pharmaceutical Technology
1
FDA's IND Pilot Puts CMC Review First
2
Driving Quality Culture to Manage Risk: Lessons from an FDA Inspection Response
3
Lessons For AI Governance in Quality Systems
4
Spray Drying Capacity Signals Faster Paths for Poorly Soluble Drugs
5