Lachman Consultant Services’ Ricki Chase sees too many companies falling down on design control activities when they set out to make combination device/drug products. Check out what she said here.
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 the complexity surrounding combination device/drug products.
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 – […]
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 […]
We are pleased to announce that Janis Picurro has accepted the position of Principal Consultant in the Regulatory Practice at Lachman Consultants, effective December 18, 2017. Ms. Picurro is a senior level regulatory professional with over 24 years of experience in the pharmaceutical industry where she had a career of progressively increasing responsibilities in Regulatory […]
We are pleased to announce that Lisa Tinsley has accepted the position of Director in the Compliance Practice at Lachman Consultants, effective December 1, 2017. Ms. Tinsley is a 25-year pharmaceutical compliance and remediation professional who has led global compliance and auditing teams, developed Quality leadership and strategies, and enhanced Quality Systems. She is well […]
We are pleased to announce that Jose L. Toro has accepted the position of Principal Consultant in the Compliance Practice at Lachman Consultants, effective November 13, 2017. Dr. Toro has extensive R&D Quality, and Quality Operations experience in the pharmaceutical industry. He specializes in the transformation of Quality and Technical Services organizations including Quality Systems, […]
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 […]
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 […]
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 […]
