Validation

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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

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 […]

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26
Nov
Thanksgiving Image

Hope at This Time of Giving Thanks

By    Nov 26, 2019    505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls […]

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20
Dec

Happy Holidays from Us to You!

By    Dec 20, 2018    ANDAs Approvals Bioequivalence Biologics Chemistry Combination Products Complex Generics Compliance Compounding Data Integrity Dietary Supplements eCTD FDA FDA Generics Guidance Manufacturing NDA News OTC Regulatory Affairs Science & Technology Shortages Training Uncategorized User Fees Validation

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]

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28
Mar
COMPLETE RESPONSE LETTERS DUE TO FAILED PAIS – MORE TO COME Image

Developments in Continuing Process Verification

By    Mar 28, 2016    Compliance FDA Generics Science & Technology Validation

The key to developing a practical approach to all phases lies in the establishment of Critical Quality Attributes (CQA) for the drug product and assignment and monitoring of Critical Process Parameters (CPP) that have a direct effect on the performance of the process with regard to the CQA. At the PDA Annual Meeting last week, Scott Bazzone, Senior Manager of Quality Assurance Validation at Pfizer presented the approach that is used there with regards to establishing the risk significance or Z Score of a CPP to the CQA.

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25
Mar

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

By    Mar 25, 2015    Compliance FDA Generics Regulatory Affairs Science & Technology Training Validation

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

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17
Mar

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

By    Mar 17, 2015    Compliance FDA Generics Regulatory Affairs Science & Technology Training Validation

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

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11
Mar

Lachman Consultant Services Presents “Data Integrity: The Foundation of Metrics”

By    Mar 11, 2015    Compliance FDA Generics Regulatory Affairs Science & Technology Training Validation

On Monday, April 20, 2015, the afternoon prior to the ISPE Quality Metrics Summit, Lachman Consultant Services will be presenting a training session on Data Integrity. The training session will be held in the Severn 1 meeting room of the Sheraton Inner Harbor Hotel in Baltimore (the same hotel as the ISPE Quality Metrics Summit), and will be followed by Q&A and a networking reception.

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14
Aug

Particulate Matter in Parenteral Products – Why So Much?

By    Aug 14, 2014    Compliance FDA Generics Regulatory Affairs Validation

Last week while waiting for my flight home at an airport on the east coast, I decided to look at the recalls listed on the CDER web page. I realize that I have read about a number of recalls of parenteral products recently and those recalls were for a number of different firms, but what caught my attention was that 12 of 25 recalls listed were for visible particulate matter (including glass particles).
While I am not a manufacturing expert by any stretch of the imagination, I started to wonder why this might be.

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