(Westbury, NY – November 2019) Spanning approximately 120 minutes, part of the executive team from Lachman Consultant Services, Inc. (“Lachman Consultants”) guided 45 young professional engineers and chemists through an introduction to current Good Manufacturing Practices (“cGMP”) during ISPE’s 2019 Annual Meeting. As a leading provider of expert compliance, regulatory affairs and technical services to life sciences clients worldwide,
Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.
Compliance 360° is hosted by Medtech Insight
LCS’ CEO, Fran Zipp, was interviewed by Economic Times during a meeting of the ISPE India affiliate.
Click here for the full interview.
LCS would like to congratulate the newly elected International Board of Directors for ISPE for 2018-2019. This Board is responsible for devising strategy and governance of ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The newly elected Board includes LCS’ own CEO and President,
The Pink Sheet recently posted an article authored by James Davison, Ph.D. Vice President of Lachman Consultants that addresses the criticality of Data Integrity outside of the laboratory.
The article highlights that regulators are making clear that issues of data integrity go well beyond what happens in drug laboratories or clinical trials and that the data compliance issues that have plagued the laboratories are relevant to areas such as manufacturing.
We are pleased to announce that Aloka Srinivasan has accepted the position of Vice President, Regulatory Practice at Lachman Consultants, effective May 14, 2018.
Dr. Srinivasan is a recognized professional with more than 15 years of experience serving at FDA and National Cancer Institute where she contributed to: establishing a DMF review division in FDA to meet GDUFA related goals;
In her new role, Linda will directly support the President and CEO serving as principal interface in key matters and delivering oversight across all Practice Areas, including program management of existing, new, and evolving projects. She will assist in the development of strategic plans and goals, advise on projects and critical issues, and continue to direct the on-going development of the Lachman brand and marketing strategy.
We are pleased to announce that Donna Gulbinski has accepted the position of Vice President, Compliance Services at Lachman Consultants, effective April 9, 2018. In this new role, Donna will report directly to me.
Ms. Gulbinski is a proven global quality leader who delivers strategic quality, compliance, and business performance services to Lachman and our clients.
Too many medical device manufacturers are struggling because they don’t have policies and systems in place to handle the ever-growing amount of data they receive about their products once they’ve gone to market. As a result, important signals can go undetected or unaddressed, leading to compliance problems and devices that are of poor quality – both of which could ultimately affect a device-maker’s bottom line.
In today’s global marketplace, industry is responsible for adhering to regulations in all markets that their products are in. Today’s pharmaceutical supply chain also likely contains partners that are across many geographic regions, and regulators expect conformity. In addition, regulators expect proactive compliance, and concerns about a retroactive “lack of assurance” of GMP are frequently the cause of a recall.
Ricki Chase, Director, Compliance Practice, will be presenting at the American Pharma Outsourcing Summit taking place September 27th and 28th, 2017 at the Doubletree by Hilton Boston North Shore. Ricki will be presenting on the Regulatory Hazards of Outsourcing, and will cover the following areas:
- Approving products on a batch-by-batch basis
- Establishing laboratory controls
- Training employees in current GMPs
- Having appropriate test procedures designed to assure standards
- Examining compliance services that are available to you
Her presentation will be taking place on Tuesday,
Wided Najahi-Missaoui, MS, PharmD, doesn’t know the meaning of the word “can’t.” Since arriving in the United States from Tunisia in 2000, she has earned two graduate degrees (a close friend says she collects degrees like others collect stamps), and accolades. Her mentor, Dr. Michael Griffith Bartlett, who is Professor and Director–BS Program at the University of Georgia (UGA) College of Pharmacy,
James Davidson, PhD, Vice President, Science and Technology practice, Lachman Consultants recently authored an article in Contract Pharma. The article, “Data Integrity Guidance Around the World”, reviews guidance issued by worldwide authorities (FDA, MHRA, PIC/S, and TGA) with regards to data integrity controls and the overall framework for a data governance system. The article can be found here.