While you are attending the AAM GRx + Biosims meeting September 5-7, 2018 at the Hilton Baltimore, please be sure to visit Lachman Consultant Services at booth 13/14 and drop your business card for a chance to win an iPad 9.7 and Apple pen! As they say, you’ve got to be in it to win it!
On September 5, 2018, at 1:30 PM, Lachman Consultant Services’ CEO and President and CEO will be moderating a panel on Data Integrity at the AAM GRx + Biosims meeting. Ms. Zipp will be joined by Derek Glover (Head of Global Quality Systems and Compliance, Mylan Pharmaceuticals Inc.), Sarah Barkow, Ph.D. (Lead Consumer Safety Officer,
We are pleased to announce that Keith Webber, Ph.D. has accepted the position of Vice President, Biotechnology at Lachman Consultants, effective September 1, 2018.
Dr. Webber delivers scientific direction, strategic guidance, and leadership regarding biotechnology products, new drugs, and generic drugs, based on his 30+ years of combined industry, U.S. FDA, and NIH experience.
We are pleased to announce that Lori-Ann Woodard has accepted the position of Director, Medical Device at Lachman Consultants, effective August 20, 2018.
Ms. Woodard delivers expertise in the implementation and management of Quality Management Systems for medical devices, Software as a Medical Device (SaMD), and combination products. She has more than 20 years of experience that includes building QMS and cGMP quality systems from the ground up,
We wanted you to be the first to know.
We at Lachman are very excited to announce our recently opened first European office. The new office is located in the heart of beautiful Switzerland near Lake Lucerne (Luzern). This centrally-located European office gives us easier access to our clients in Europe, Asia, and the surrounding regions.
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.
On May 3, 2018 at the Food Drug and Law Institute’s Annual Conference, LCS’ President and CEO Fran Zipp participated in a panel with CDER Director Janet Woodcock. Other panelists included Margaret Anderson (Deloitte), Daniel Kracov (Arnold & Porter LLP), and Peter Pitts (Center for Medicine in the Public Interest), moderated by Carla Cartwright (JnJ).
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.
We are pleased to announce that Constance Richard-Math has accepted the position of Director in the Compliance Practice at Lachman Consultants.
Constance Richard-Math joined Lachman Consultants after a 20-year career at the U.S. Food and Drug Administration where she rose to the position of Director, Investigations Branch at the Baltimore, Maryland District Office.
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 FDA inspections, interactions and expectations.
Compliance 360° is hosted by Medtech Insight
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 – 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.