Data integrity is not only fundamental to a company’s license to operate and to drive new stakeholder value. It’s simply smart business. Does your company have a sustainable, cost-effective global data governance program? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely […]
The 2022 PDA Universe of Pre-Filled Syringes and Injection Devices conference was held in Palm Springs, CA, October 18-19, 2022. In attendance were some of the world’s largest providers in this combination space which included innovators, pharmaceutical companies, suppliers of injectable devices and contracted service providers. The conference speakers presented on a variety of topics […]
For those facilities compounding drug products and distributing them out of state, the FDA has extended the statutory enforcement date. On the Federal Register prepublication page this morning, the Agency announced that it is “extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products […]
A strong organizational culture is essential for maintaining the quality and integrity of your company’s data. Does your company have a data-integrity-centric culture? Get the answers you need. Watch the following video and talk to Lachman Consultants. The primary purpose of this message is solely to educate and inform. Lachman Consultants Services, Inc. assumes no […]
The PDA Quality & Regulations Conference was held on October 5 and 6, 2022 in Amsterdam; it was healthily attended by a variety of multi-national pharma manufacturers as well as representatives of regulatory bodies from multiple EU countries as well as the USFDA. The agenda was very much data‑driven as presenters focused on how data […]
As former OGD Director Kathleen “Cook” Uhl, MD used to say, “Read the commitment letter.” This certainly applies for GDUFA III and in spades. Why? Because a number of enhancements that were made in the GDUFA III negotiations are designed to make the review process more efficient and improve the number of first‑cycle approvals. In GDFUA I and […]
Earlier this year, we posted about FDA’s new revision for the OOS Guidance for Industry. The new revision allows ‘averaging’ results from a pool of replicate results even though one of them is OOS for ‘certain circumstances.’ This was the most significant change in this revision. So the question is, can you always average? If […]
The 16th annual WRIB (Workshop on Recent Issues of Bioanalysis) is being held in Atlanta, GA this week with approximately 800 attendees at the workshop. The workshop which runs through Friday, is well represented by regulators from across globe, and industry (both from Pharma and CROs) with numerous discussions and topics for bioanalysis ranging from […]
If our supply chain was weak prior to the pandemic, this global event accelerated its failure. These signals of weakness were laid bare during the pandemic and identified in publications such as the 2019 report “Drug Shortages: Root Causes and potential Solutions” (here). Prior to the Covid PHE, focus on shortages was placed much more […]
During the 2022 PDA Data Integrity Workshop held on September 15th and 16th, in Washington, D.C., the topic of “rewards for meeting Quality Metrics” was mentioned several times. You may have been the recipient of a work-related incentive at one time or another during your career for meeting a Quality Metric or for achieving some […]
