compliance360

Compliance 360 – An 8-part 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.

PODCAST LINEUP

February 6
Handling Difficult US FDA Investigators

February 13
Getting The Most Out Of Your Inspection:
Close-Out Meetings

February 20
Building Trust With US FDA:
Can It Be Done?

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.

12th Annual Scrip Awards

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,
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Women in Pharma Debuts at 2016 ISPE Annual Meeting & Expo

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,

The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

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!

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,

LCS to Exhibit at the ISPE/FDA/PQRI Quality Manufacturing Conference

On June 6-8 at the Bethesda North Marriott Hotel, ISPE will be hosting the 4th annual Quality Manufacturing Conference, in collaboration with FDA and PQRI. Lachman Consultants is the sponsor of the Welcome Reception as well as the conference badges. In addition, we will be exhibiting in the hall at table 3. Please stop by our booth for a chance to win an iPad,

White Paper: Navigating Through the Clouds in Life

Whether we embrace it or not, the Data and Application economy is upon us. Every business is, in some respects, a digital business, and in the digital realm things change FAST.

The term ‘cloud’ as a technology concept has been in use since at least 1971, but even as recently as 2009 companies like IBM were just introducing it to prospective clients.

White Paper: The Real Cost of Poor Data Integrity in Pharmaceutical Manufacturing

Every business faces risk. Broadly speaking, the primary categories of business risk are Market, Financial, Execution, and Regulatory. Successful companies have developed a core competency in managing for these risks, turning risk management into a sustainable competitive advantage. For drug manufacturers, recent trends have underscored the importance of managing Regulatory risk in order to remain a viable business.