Compliance 360 – A podcast survival guide to US FDA enforcement and compliance

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

PODCAST LINEUP

October 23

Compliance 360° Part 10: Turn Your CMO Nightmare Into A Dream Come True (1 of 2)

June 5
Compliance 360° Part 9: US FDA Is Looking Closely At Process Validation – Are You Ready?

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.

Michael L. Keech, M.B.A. New Head of Business Strategy at Lachman Consultant Services, Inc.

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,

Linda Evans O’Connor, M.B.A. Promoted to Head of Business Processes and Regulatory at Lachman Consultant Services, Inc.

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.

Daniel Barreto, New Vice President, Compliance Practice at Lachman Consultant Services, Inc.

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.

Ricki A. Chase, New Director, Compliance Practice at Lachman Consultant Services, Inc.

We are pleased to announce that Ricki A. Chase will join Lachman Consultants as a Director in the Compliance Practice, effective June 20, 2016.

Ricki Chase comes to Lachman Consultants after an impressive 16-year career, culminating as Director, Investigations Branch at the U.S. Food and Drug Administration where she was responsible for all operations of the Investigations Branch,