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,
We are pleased to announce that David Lonza has accepted the position of Head of EU at Lachman Consultants, effective September 1, 2017.
David Lonza joined Lachman Consultants in August 2016, in the role of Deputy Advisor to the President / CEO – Strategic Initiatives. David’s expertise includes servicing pharmaceutical / biopharmaceutical / biotech clients to meet International Regulatory challenges and Operational Readiness.
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.
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,
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
Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?
On May 8, 2017, the US FDA’s Center for Radiological Health announced that it will be establishing a new digital health unit under the Office of the Center Director. This is just the latest step the Agency is taking to try to keep pace with the quickly evolving and rapidly growing digital medical device industry.
On April 27, 2017, Linda Evans O’Connor, Head of Business Processes and Regulatory, presented at the 2nd Healthcare Asia Pacific Summit 2017 in Singapore. She presented on international regulatory trends, FDA enforcement actions for foreign and domestic firms, the new US Administration and effect on expected guidances, and quality culture.
James Davidson, Ph.D., Vice President, Science and Technology, will be moderating a session at the Food and Drug Law Institute Annual Meeting in Washington, D.C. The session, “Responding to and Remediating Data Integrity Issues in a 483 or Warning Letter’, will take place on Friday, May 5 at 12:30 PM in the Ronald Reagan Building and International Trade Center,
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 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.
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.
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.
We are pleased to announce that Michael Keech will join Lachman Consultants as Head of Business Strategy, effective January 3, 2017.
Mr. Keech comes to Lachman Consultants as a seasoned Quality, Compliance and Manufacturing professional who has worked in the Life Sciences field for over 25 years. Mr. Keech has helped global corporations transform into world-class organizations by providing strategic and tactical guidance on regulatory requirements and compliant solutions involving the clinical and commercial manufacture/control for pharmaceutical,
We are pleased to announce that Linda Evans O’Connor, M.B.A. has been promoted to Head of Business Processes and Regulatory at Lachman Consultant Services, Inc. Ms. Evans O’Connor will continue in her recognized leadership role as part of the Compliance Practice and will oversee the administrative activities of the Regulatory Department as well as support the on-going development of the Lachman brand and marketing strategy.
We are pleased to announce that Daniel Barreto will join Lachman Consultants as Vice President, Compliance Practice, effective December 12, 2016.
Mr. Barreto comes to Lachman Consultants with nearly four decades of extensive international experience in the pharmaceutical industry developing and implementing quality strategies and programs to support a continuous state of compliance and consistent state of inspection readiness.