Data Integrity

13
Sep
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How Mature is Your Quality Management Program?

The FDA has issued a white paper on “CDER’s Quality Management Maturity (QMM) Program: Practice Areas and Prototype Assessment Protocol Development.” The paper details a program the center intends to establish whereby the goal is to promote QMM throughout the industry. Lachman recently issued a blog relating to this initiative that can be found here. […]

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07
Sep
PDA Pharma Mfg Conference 2023 1- Lachman Consultants

The Singapore PDA Manufacturing and Quality Conference – The Future of Pharma in a City of the Future

As Asia’s top financial hub and one of the top five busiest shipping ports in the world, Singapore is also one of Asia’s most modern. Recognized for its focus on strategic urban planning and renovation, innovative architecture, green sustainable initiatives, cultural diversity and high living standards, Singapore is a business-friendly city of high aspirations and […]

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24
Aug
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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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09
Aug

Don’t Miss Our Talk on Data Integrity for Sterile and Non-Sterile Mfg at the 2023 PDA Pharma Mfg & Quality Conference!

Join Lachman Consultant Services, Inc. at PARKROYAL on Beach Road, Singapore for the 2023 PDA Pharmaceutical Manufacturing and Quality Conference, August 15th – 16th. The conference theme is “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing.” Lachman Consultants is pleased to have Scott Deckebach, Senior Director of Data Integrity and Compliance, as […]

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03
Aug

Connect with Lachman Consultants at ISPE Singapore Affiliate Conference & Exhibition August 23 – 25, 2023

Join Lachman Consultant Services, Inc. online and in-person at Suntec Singapore for the 2023 ISPE Singapore Affiliate Conference & Exhibition, August 23rd – 25th. The exhibition showcases the latest technologies and services for pharmaceutical and biomanufacturing. The three-day conference is expected to include more than ninety international exhibitors and sponsors. Lachman Consultants is pleased to […]

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02
Aug
Deadline.

Risk Meets Data Governance in the Supply Chain 

What do a cup of cappuccino and sterile water for injection have in common?  At first glance, there is no apparent correlation, except when you become “data curious” and take the macro view of the current convergence of economics, compliance, and maturation of risk management.  Sometimes utilizing existing data is the best way to understand […]

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09
Jun

Supply Chain Risk and Data Management Poised to Take a Leap Forward

In a complete supply chain, one site’s lag measure is another site’s lead measure.  As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients.  As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]

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15
May

Supply Chain Resilience and the Value of Digitization and Data Themed at the 2023 ISPE Europe Annual Conference in Amsterdam

Amsterdam’s iconic concentric circles of interlocking canals, its international appeal and its historical role in shaping our modern world provided the perfect backdrop for the 2023 ISPE Europe Annual Conference which, in Amsterdam fashion, served as a focus  for some of the pharmaceutical industry’s most important and contemporary challenges –forces which will most certainly reshape […]

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08
May

Digitization and Future Highlighted at the May PDA Robotics and Automation Conference in Amsterdam

The 2023 PDA Robotics and Automation Conference, which just concluded in Amsterdam, Netherlands, highlighted the significant new value and promise of advanced technologies, robotics, automation and digitization across the pharmaceutical value chain from clinical to manufacturing to distribution, and for all sectors including small and large molecule and medical device.  Conference presentations and panels highlighted […]

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13
Apr
Clinical Study Monitoring - Lachman Consultants

Q&A Document On Clinical Study Monitoring Offers Additional Information

The monitoring of clinical studies is extremely important to protect the rights, welfare and safety of the study participants, and to assure the integrity of the study data submitted to the FDA and thus, ultimately the accuracy of FDA’s evaluation of submitted studies and subsequent approval decisions.  If you have been following the debarment notifications […]

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