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.
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,
ISPE presented the first in a series of planned annual events entitled, “The Women in Pharma” on Monday 19 September at its 2016 Annual Meeting. Key female pharmaceutical industry executives shared their stories at the morning session, focusing on the challenges and opportunities each embraced as they progressed though their careers.
The session was led by Charlotte Enghave Fruergaard,
Lachman Consultants will be exhibiting at the ISPE Annual Meeting & Expo in Atlanta from September 18-20. Please come visit us at booth 54 and pick up some of our White Papers on Cloud Computing and Data Integrity. See you in Atlanta!
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 on a job well done!
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.