25
Sep

Lachman Consultants to Participate at This Year’s GRx+Biosims 2023 in October

Join Lachman Consultants at GRx+Biosims™ 2023 in North Bethesda, MD, Oct 2 – 4 for three days of insights and engaging discussions around the most pressing issues vital to the generics and biosimilars industry. Lachman will be represented by several members of the team, including: Frances Zipp, President & CEO Bob Pollock, M.S., Outside Director […]

Read More
12
Sep

Lachman to Participate at the PDA/FDA Joint Regulatory Conference

Join Lachman Consultants in Washington, DC, Sep 18-20, for the 2023 PDA/FDA Joint Regulatory Conference. Themed “CGMP: Quality Through Science and Innovation,” this year’s event will delve into the pivotal role effective quality systems play in ensuring an ongoing state of control throughout the product lifecycle. As a Silver Sponsor at this year’s event, Lachman […]

Read More
24
Aug
Mock-Inspection-Blog-image-Lachman-Consultants

5 Reasons Why You Should Perform a Mock Inspection Now

As U.S. consumers are facing critical drug shortages, leading Congress to question the FDA’s foreign inspection program, particularly for products with supply chains from India and China, the oversight of CGMP inspections is high on the Agency’s radar. With approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) from these two countries, […]

Read More
17
Aug

Short Course: Aseptic Manufacture and Annex 1 with Lachman Consultants

Lachman Consultants (Ireland) and NIBRT have partnered to offer a short course to help directly address Aseptic Manufacturing Compliance, including Annex 1 requirements, developing implementation strategies, maturity assessment, and planning for sustainable improvements. Course Date: 4th October 2023 Location: On-site at NIBRT – Dublin, Ireland Learn more about the course, including who should attend, learning […]

Read More
11
Aug
MCCH Backpack Donation - Lachman Consultants

Lachman Gives Back to the Local Community

Over the years Lachman Consultant Services, Inc. has participated in and donated to volunteer-based and charitable organizations as part of our corporate social responsibility (CSR) program. Our overarching value is in our ability to assist our clients as they help their patients, but equally as important is using our skillsets and our reach to help […]

Read More
09
Aug

Don’t Miss Our Talk on Data Integrity for Sterile and Non-Sterile Mfg at the 2023 PDA Pharma Mfg & Quality Conference!

Join Lachman Consultant Services, Inc. at PARKROYAL on Beach Road, Singapore for the 2023 PDA Pharmaceutical Manufacturing and Quality Conference, August 15th – 16th. The conference theme is “The Way Forward: Trends, Technologies and New Regulations Transforming Pharmaceutical Manufacturing.” Lachman Consultants is pleased to have Scott Deckebach, Senior Director of Data Integrity and Compliance, as […]

Read More
24
Apr

We’ll see you at the 2023 PDA Robotics and Automation Conference

Lachman Consultant Services, Inc. is proud to be a Gold Sponsor of the 2023 PDA Robotics and Automation Conference. Taking place on Wednesday, May 3rd and Thursday, May 4th, 2023, in Amsterdam, The Netherlands, the two-day gathering builds a roadmap to digitization designed for drug manufacturing. This annual conference is designed to catalyze the transition […]

Read More
19
Apr

Top Risks of the 510(k) Premarket Notification Process

As with any regulatory submission, there are inherent risks associated with the submission and approval process if required data are incomplete or missing.  In addition, compliance activities can play a major role in risks following approval and with commercialization of products. Some of the risks specific to 510(k)‑cleared devices include: Submission Rejection/Approvals: FDA 510(k) submissions […]

Read More
21
Mar

We’ll be looking for you at the 2023 PDA Annual Meeting

Visit with Lachman Consultants at Booth #600. The PDA Annual Meeting is a must-attend event for professionals in the pharmaceutical and biopharmaceutical industries. The three-day 2023 event is being held on Monday, April 3rd to Wednesday, April 5th at the Hyatt Regency New Orleans. As a leading forum for knowledge-sharing and networking, this year’s event […]

Read More
1 2