Newsletter | March 6, 2013

03.06.13 -- How to Survive An FDA Audit; Quality by Design; Enterprise Serialization

Pharmaceutical Online Newsletter
Dosage Form Production Packaging/Assembly Logistics Drug Substance Production
Featured Focus: Dosage Form Production
Quality By Design, Should Pharma And Biotech Suppliers Be Ready?
By Wayne Koberstein, Life Science Leader
Quality by design, oh my … is it salvation or mere vexation for manufacturing and other suppliers to pharma and biotech companies — or something else entirely?
ARTICLE: Building Productivity: Automating Time And Attendance In Manufacturing
By Mollie Lombardi, Vice President, Principal Analyst, Human Capital Management at Aberdeen Group
Manufacturing organizations always face a critical balancing act. They must achieve the highest levels of efficiency possible, while also ensuring that they are not over or under supplying the marketplace.
Q&A: Drug Delivery Insights From A 30-Year Veteran At 3M
By James Ingebrand, President and General Manager for 3M
James Ingebrand, president and general manager for 3M Drug Delivery Systems, joined 3M back in 1984. Having worked across a number of 3M's divisions in the United States and the United Kingdom, both on the branded and OEM sides of the business, Ingebrand has rich insight into industry trends as well as 3M's history of innovation.
» Packaging/Assembly
ARTICLE: How To Survive An FDA Audit
By Paul Dupont, Ropack
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater access to records, and conducting audits more frequently — up from .06 to .09 per year, according to Bloomberg News.
ARTICLE: What Is Enterprise Serialization?
By John DiPalo, Chief Operations Officer
For those who haven't checked their watch lately, we'd like to remind you there are only two years until California's serialization mandates take effect.
WHITE PAPER: OEM Disposable Medical Device Outsourcing
By Donald J. Dobert, President, ATL Medical-Pharmaceutical
Follow these ten tips to clearly define your needs and the function of the product. Your vendor may be able to suggest cost-efficient ways to improve product quality and lower unit price.
» Logistics
CASE STUDY: Cenetron Diagnostics Gains Better Control Of Temperature-Sensitive Shipments For Clinical Trials
CASE STUDY: A Healthcare Company's Quality Manufacturing Issues Required A Time-Definite Delivery Solution
NEW PRODUCT: Remote Monitoring
PRODUCT: Certis Insulated Shipping Containers
» Drug Substance Production
CASE STUDY: A High-Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs)
NEWS: Cedarburg Hauser Granted DEA Registration For Denver Manufacturing Facility