01
Mar

Lachman Consultants to Offer Insights on Future Transition of Biological Products at the 2019 Parenteral Drug Association (PDA) Annual Meeting

(Westbury, NY – February 2019) Lachman Consultant Services, Inc., a leading provider of expert compliance, regulatory affairs and technical services to life sciences organizations worldwide will be a Bronze Sponsor at the 2019 Annual Meeting of the Parenteral Drug Association (PDA), Booth #308, March 11-13, at the Marriott Marquis San Diego, San Diego, CA. Themed […]

Read More
29
Jun
Quality Concept: Arrow of A Compass Pointing Quality Text

Quality Metrics- The Next Step

Over a decade ago, the FDA issued a final report on Pharmaceutical Quality for the Twenty-First Century. As time moved forward, this led to the FDA’s Center for Drug Evaluation and Research through the creation of the Office of Pharmaceutical Quality, to launch “FDA Pharmaceutical Quality Oversight: One Quality Voice” (here), which attempts to develop […]

Read More
01
Dec
Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance Image

Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down: Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from […]

Read More
23
Nov

12th Annual Scrip Awards

On November 30, 2016, the 12th Annual Scrip Awards will be held at the Grosvenor House Hotel, Park Lane, London. Lachman Consultants is proud to be a sponsor of the Executive of the Year category. We would like to congratulate all of the finalists in this category: Eliot Forster, CEO of Immunocore Mireille Gillings, Founder […]

Read More
21
Aug

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

An article authored by Jim Davidson, Ph.D, Vice President, recently appeared in the July-August issue of Pharmaceutical Engineering. This very timely article, “The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing”, has also been the subject of White Papers authored by LCS, as well as the topic of numerous industry symposia. Congrats to Jim […]

Read More
29
Jun

Technical Reference Document Letter

On June 27, 2016, FDA announced in the Federal Register the issuance of a Technical Reference Document titled “Quality Metrics Technical Conformance Guide”. This Guide is meant to supplement the FDA Guidance titled “Request for Quality Metrics” in that it provides technical recommendations for the submission of quality metrics data called for in the Guidance. […]

Read More
20
May
Is FDA Starting to Think (Again) About Cloud Computing Image

Is FDA Starting to Think (Again) About Cloud Computing?

In April 2016, the FDA published its much-anticipated draft Guidance on Data Integrity. This Guidance is a great way for industry and FDA to start and continue the dialogue about data integrity. An interesting note about this Guidance is that buried, deep down on line 142, is a mention of “cloud infrastructure” as a “system” as it relates to “computer or related systems” in § 211.68. Up until this point, the FDA has been largely silent on the use of cloud computing for FDA regulated systems, and industry has taken this silence to be, in many ways, a prohibition to its use.

Read More
1 3 4 5