Data Integrity

Lachman Consultant Services, Inc. / Blog / Data Integrity
03
Aug

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

By    Aug 03, 2023    Biologics Data Integrity Manufacturing News Pharmaceutical industry

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 […]

Read More
02
Aug
Deadline.

Risk Meets Data Governance in the Supply Chain 

By    Aug 02, 2023    Data governance Data Integrity Data maturity Quality Management Maturity (QMM) Quality strategy Regulatory intelligence Supply chain Supply Chain Resilience

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 […]

Read More
09
Jun

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

By    Jun 09, 2023    ANDAs Compliance Data Integrity Drug Shortages FDA ICHQ9 NDA Regulatory Affairs Risk Management Supply Chain Resilience

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 […]

Read More
15
May

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

By    May 15, 2023    Compliance Data Integrity Validation

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 […]

Read More
08
May

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

By    May 08, 2023    Compliance Data Integrity FDA Regulatory Affairs

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 […]

Read More
13
Apr
Clinical Study Monitoring - Lachman Consultants

Q&A Document On Clinical Study Monitoring Offers Additional Information

By    Apr 13, 2023    ANDAs BLA Clinical Studies Data Integrity FDA Monitoring NDA

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 […]

Read More
14
Dec
Data Analysis for Business and Finance Concept

Digitization and Future Highlighted at the ISPE Pharma 4.0 and Annex 1 Conference

By    Dec 14, 2022    Compliance Data Integrity Digitization

The 2022 ISPE Pharma 4.0 and Annex 1 Conference, which just concluded in Vienna, Austria, highlighted the exploding value of digitization in pharmaceutical aseptic manufacturing and quality, and how digitization will play a key role in the attainment of sustainable and robust compliance for the new revision of EU GMP Annex 1 for manufacture of […]

Read More
12
Dec

Are your Analytical Methods Processing Settings Part of Your Analytical Lifecycle Management Program?

By    Dec 12, 2022    Analytical Methods Data Integrity FDA

Processing of the laboratory instrumentation output such as the processing of chromatographic raw data continues to be a focus of global  health agency investigators. This is not surprising, as the investigator will be aware of the Data Integrity (DI) risks with such a manual operation, where there is the potential of selectively adjusting integration settings […]

Read More
21
Nov

FDA Inspections Summit: Emerging from Covid and the Future of Data Integrity

By    Nov 21, 2022    Compliance Data Integrity FDA

The 17th Annual FDA Inspections Summit kicked off with high energy by keynote speaker Elizabeth Miller, Pharm.D., Assistant Commissioner for Medical Products and Tobacco Operations Regulatory Affairs who presented on the FDA perspective on inspections.  As the entire world emerges from the pandemic, it was reported that the ORA is holding “listening sessions” to see […]

Read More
07
Nov

The ISPE Annual Meeting Highlights Quality’s Mandate in the Age of Digitization

By    Nov 07, 2022    Compliance Data Integrity FDA Quality

This year’s ISPE Annual Meeting and Expo in Orlando highlighted a number of key topics and trends in our industry’s digitization journey. These covered everything from industry progress with manufacturing and laboratory automation and digitization to trends in new technologies like blockchain and ways to modernize quality organization and systems to be digital future ready. […]

Read More

Subscribe to our blog

Recent Articles

Contact Us:



1 2 3 4 … 6
2024 © Lachman Consultant Services, Inc.Terms and ConditionsPrivacy Policy