Aloka Srinivasan, Ph.D., New Vice President, Regulatory Practice at Lachman Consultant Services, Inc.

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;

We are pleased to announce that Linda Evans O’Connor has been promoted to VP, Chief of Staff.

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.

Donna Gulbinski, new Vice President, Compliance Services at Lachman Consultant Services, Inc.

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. 

From Big Data To Cybersecurity, Today’s Device-Makers Face Myriad Compliance Risks – But Being Proactive Can Pay Off, Ex-FDA Official Says – article in Medtech Insight by Lachman Consultants

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.

Anticipating trends in regulation – how do you get your information, and what do you do with it once you do?

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, M.S., Director, Lachman Consultants, to Present at American Pharma Outsourcing Summit

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,

UGA’s Wided Najahi-Missaoui Granted First Women in Pharma Scholarship (iSpeak blog, ISPE, September 8, 2017)

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,

Article published in Contract Pharma by James Davidson, PhD

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.

Lachman Consultants Participates in the ISPE/FDA/PQRI Conference

A few weeks ago, Lachman Consultants participated in the ISPE/FDA/PQRI Quality Manufacturing Conference (“Conference”) in Alexandria, VA. For those that have never attended, this is a particularly dynamic meeting for those that are involved in manufacturing in the regulated industry. There were a myriad of presentations and workshops with members of FDA and industry professionals,

Jean Poulos, M.S, M.B.A., new Principal Consultant at Lachman Consultant Services, Inc.

We are pleased to announce that Jean Poulos has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective April 10, 2017.

Ms. Poulos is a seasoned Regulatory professional with more than 25 years of combined quality assurance, quality control, regulatory affairs and compliance enforcement experience in the pharmaceutical / biotechnology industries. 

Paul F. Vogel retires as Chairman of the Board, Richard S. Bowles, III, Ph.D. assumes the role

Paul F. Vogel has announced his retirement as Chairman of the Board of Lachman Consultants, effective March 31, 2017. Paul plans to spend more time with family and his many personal interests, following a 44-year career that included 21 years at the U.S. Food and Drug Administration followed by 23 years at Lachman Consultants. Richard S.

Challenges and Advantages of International Regulatory Inspections, by Dan Barreto, VP, Compliance

Every year, FDA and key worldwide regulatory authorities perform foreign inspections of production facilities around the world. All inspections share a common goal: to ensure the products shipped to their respective countries will comply with the core requirements for safety, efficacy, quality, purity, and regulatory commitments. While foreign regulatory agencies merit respect, the FDA and U.S.

Sharif Ahmed, M.S, RAC, new Principal Consultant at Lachman Consultant Services, Inc.

We are pleased to announce that Sharif Ahmed has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective February 20, 2017.

Mr. Ahmed has been functioning as a Senior Associate in the Regulatory Practice at Lachman Consultants since January 2016. He is a seasoned Regulatory professional with nearly 30 years of progressive responsibilities and is highly knowledgeable of the product approval processes of both the U.S.

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