Compliance Archives - Page 17 of 59 - Lachman Consultant Services, Inc.

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

By Webmaster Lachman Dec 08, 2020 Compliance Coronavirus Data Integrity Drugs Emerging Technology Facilities FDA FDA Generics Inspections Laboratories Manufacturing Medical Devices Regulatory Affairs Science & Technology

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

Nov

Price Saving’s Short-Sighted Action by HHS – Unapproved Drug Initiative – Cancelled!

By Bob Pollock Nov 24, 2020 Compliance FDA Generics Regulatory Affairs Unapproved Drugs

I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market. Firms need to […]

Nov

Lachman Consultants Wishes You a Happy Thanksgiving

By Bob Pollock Nov 23, 2020 BLA Compliance FDA Generics Regulatory Affairs

At first blush, it does not seem like we have that much to be thankful for in 2020, between the pandemic, polarized political views, a contentious election, worry about loved ones, quarantine and stay at home orders, restaurants closing and opening, only outside eating, and hospitals jammed packed and people dying, jobs disappearing and Federal […]

Nov

Mission Critical Inspections, What About Me? What’s a Body to Do?

By Fran Zipp Nov 12, 2020 Biologics Compliance FDA Generics New Drugs Regulatory Affairs

Two prominent senators recently sent a letter to the Commissioner of the FDA on November 10, 2020, requesting him to provide certain information regarding the current state of conducting international inspections. Many of those within and supportive of the pharmaceutical industry applaud the efforts of these senators in shining a light on some elements associated […]

Nov

Congress Finds Interest in Foreign Inspection Postponements Due to the Pandemic

By Michele Sinoway Nov 11, 2020 Compliance FDA Generics Inspections Regulatory Affairs

In March 2020, the FDA postponed all inspections of domestic and foreign drug manufacturing facilities due to the COVID-19 pandemic. However, drug products manufactured overseas are still entering the U.S. market, prompting some U.S. Senators to voice their concern. On November 10th, two members of the Senate Health, Education, Labor, and Pensions (HELP) Committee sent […]

Nov

Generic Drugs, Product Quality, and DSCSA Overviews in AAM Morning Sessions

By Bob Pollock Nov 10, 2020 Compliance FDA Generics Regulatory Affairs

Another day, another early morning on the West coast. While I am an early riser, 5:30AM is even a chore for this old FDA-er! But here we go! The morning began at the AAM GRx-Biosims meeting with Dr. Sally Choe, Director of the Office of Generic Drugs, as she provided a current program summary. We […]

Nov

Scott Deckebach to Participate in Virtual Panel Discussion on the “New Normal” for Quality Practices During Pandemic

By Bob Pollock Nov 09, 2020 Compliance FDA Inspections News Quality Virtual Inspections

On November 11, 2020, Lachman’s Scott Deckebach MBA, Director, Compliance, Lachman Consultants will be participating in a panel discussion during the 2020 Bio/Pharma Virtual Congress, “‘New Normal’ for Quality Practices”. This discussion will review quality and regulatory challenges amid the pandemic, focusing on new technologies such as remote monitoring, risk-based quality management, Annex 1 changes […]

Nov

Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

By Linda Evans O'Connor Nov 04, 2020 Compliance FDA Inspections

According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP audits and inspections using interactive video or other types of interactive tools and techniques. He noted that many companies have volunteered use of […]

Oct

Along with Witches, Time Flies By

By Roy Sturgeon, PhD. Oct 29, 2020 Compliance Compounding FDA Regulatory Affairs

How long has it taken for a Final Standard Memorandum of Understanding (MOU) for States regarding Compounding Pharmacies to be issued? Are States or appropriate agencies (referred to as States below) ready to sign, acquire infrastructure, hire the necessary human resources, develop the enabling documentation, execute the requirements of the provisions, create the necessary records, […]

Oct

Businessman examines a tablet with a magnifying glass. Concept of internet security

Understanding Risk as It Applies to Data Integrity

By Paul Mason, PhD. Oct 22, 2020 Compliance Data Integrity FDA

The PDA published Technical Report 84, Introducing Data Integrity Requirements into Manufacturing and Packaging Operations (here), which reaffirms that Data Integrity is not only a concern for the laboratory but for any aspect of the pharmaceutical industry where data/records are generated and handled. There are excellent tools within the document as it applies to the […]

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Compliance

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

Price Saving’s Short-Sighted Action by HHS – Unapproved Drug Initiative – Cancelled!

Lachman Consultants Wishes You a Happy Thanksgiving

Mission Critical Inspections, What About Me? What’s a Body to Do?

Congress Finds Interest in Foreign Inspection Postponements Due to the Pandemic

Generic Drugs, Product Quality, and DSCSA Overviews in AAM Morning Sessions

Scott Deckebach to Participate in Virtual Panel Discussion on the “New Normal” for Quality Practices During Pandemic

Is FDA Finally Ready to Use Advanced Technology to Perform Inspections During the Pandemic?

Along with Witches, Time Flies By

Understanding Risk as It Applies to Data Integrity

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