Medical Devices

24
Aug
Mock-Inspection-Blog-image-Lachman-Consultants

5 Reasons Why You Should Perform a Mock Inspection Now

As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]

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19
Apr

Top Risks of the 510(k) Premarket Notification Process

As with any regulatory submission, there are inherent risks associated with the submission and approval process if required data are incomplete or missing.  In addition, compliance activities can play a major role in risks following approval and with commercialization of products. Some of the risks specific to 510(k)‑cleared devices include: Submission Rejection/Approvals: FDA 510(k) submissions […]

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26
Oct

Data Integrity Series: Episode 6

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 […]

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18
Oct

Data Integrity Series: Episode 5

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 […]

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26
Sep

Data Integrity Series: Episode 4

Episode #4 of our six-part Data Integrity video series focuses on Systems and Processes, two more essential elements for minimizing and eliminating data integrity issues. The video explains the four key points of Systems and Processes necessary for establishing a world-class data integrity program and the two primary controls that well-established Systems and Processes provide. […]

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08
Sep

Data Integrity Series: Episode 3

Our latest video in the Lachman Consultants Data Integrity Series, “People and Organization – The First Essential Elements of a World-Class Data Integrity Program” reveals how good people and organization practices can have a most pronounced impact on reducing your overall data integrity risk. How well is your company incorporating people and organization into its […]

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10
Aug

Data Integrity Series: Episode 2

Traditionally, data integrity programs have focused on electronic systems, but to keep pace with the industry, your company must evolve. Achieving digital maturity requires companies to develop a multi-dimensional program of governance for their data. Learn what a well-conceived program that achieves lasting data integrity consists of. “The primary purpose of this message is solely […]

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06
Jun

FDA Withdraws Covid Q&A Document as the FDA Returns to a Semblance of Normalcy

In a Federal Register notice titled Effects of the COVID‑19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices–Questions and Answers (Revised); Withdrawal of Guidance (Docket No. FDA-2020-D-1138), which appeared in the prepublication section (usually meaning it will become official the next day but, because of the weekend, the final publication […]

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