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Fran Zipp, President & CEOThe multidisciplinary team at Lachman provides clients with deep quality, compliance, performance improvement, information technology and organization change management insights at all levels, from the c-suite to operations. Their practical, realistic, and actionable guidance is designed to work within each client’s unique organization and global culture. Using an approach grounded in delivering sustainable compliance with robust, interlinked processes and systems, Lachman helps organizations in responding to problems, maintaining compliance and preventing nonconformities from occurring.
Offering a full portfolio of capabilities, Lachman works with clients to create a continual improvement process that identifies the root cause of compliance gaps. Moreover, Lachman focuses on identifying and evaluating trends to help them to anticipate and address potential future risks based on emerging changes in regulation or business conditions. “Our results have consistently held up to regulatory scrutiny across the globe. We are committed to providing our clients with services that are designed to enhance competitive positioning and operational performance to achieve bottom-line growth and avoid costly government actions,” states Fran Zipp, President and Chief Executive Officer, Lachman Consultants.
With its value proposition in the pharmaceutical compliance space, Lachman’s expertise covers lifecycle stages, company structures, and objectives. Their experienced practitioners and integrated set of solutions span the global quality and regulatory landscape. Zipp explains, “Our professionals average 15 years of experience from both industry and regulatory agencies. Their exceptional backgrounds allow them to understand the context, risk, resources, and practicalities of navigating an increasingly aggressive global regulatory environment.”
Our results have consistently held up to regulatory scrutiny across the globe. We are committed to providing our clients with services that are designed to enhance competitive positioning and operational performance to achieve bottom-line growth and avoid costly government actions
Lachman plans to continue its focus on helping clients in all aspects of global quality and regulatory compliance, working to proactively address quality and compliance issues. Zipp elaborates, “We have observed many clients working diligently to do what is right to assure patient safety and comply with the regulations. It is our experience that they work so hard at that piece that they overlook the maintenance component which leads to sustainable compliance.” Lachman’s approach integrates key components including the analysis and auditing of current operations, development of a proactive quality and compliance strategy, Corrective and Preventive Action Plans (CAPA), tailored quality training programs and organizational change management to drive compliance sustainability, which leads to better outcomes for clients and the public health. Having worked with many companies to evaluate quality systems, Lachman has a deep knowledge and understanding of the current industry best practices regarding design and implementation of sustainable systems. Whether it is a review of existing systems, or a full implementation of a quality system, Lachman can help companies prevent and resolve compliance problems at all stages of development and/or production of new or existing products subject to review and approval by FDA.
Company
Lachman Consultants
Management
Fran Zipp, President & CEO
Description
A provider of compliance, regulatory affairs, and technical consulting services to clients in the pharmaceutical and allied health industries around the world
Distinguished professionals in the field, including regulatory authorities, manufacturers, and CDMOs, will be generously sharing their insights and expertise with conference attendees. Topics of discussion encompass APIs, ATMPs, CGT, MRNAs, OSD, biologics, vaccines, and their associated subjects. The comprehensive conference program, which spans online symposiums, on-site presentations, and live-streamed tracks, delves into areas such as digital transformation/pharma 4.0, digital CQV, regulatory practices, compliance, quality assurance, C&Q, Annex 1, CCS, GAMP5, sustainability, and supply chain management, among others. Participants will also be kept abreast of the latest advancements and updates pertaining to aseptic/sterile conditions, single-use systems, multi-modal approaches, as well as flexible and continuous manufacturing methods. As part of the 2023 event, attendees can engage in twenty-two immersive workshops and benefit from thirty-two daily 'Power Hour' sessions that provide additional learning opportunities at no cost.
Scheduled for Wednesday, August 23rd, Scott Deckebach, Senior Director of Data Integrity and Governance at Lachman Consultant Services, Inc., will be delivering the Keynote Presentation titled: "The Convergence: Data Integrity & Pharma 4.0." Furthermore, on August 24th, Scott will be actively participating in the workshop themed "Establishing an Effective Data Integrity Program for Long-term Sustainability."
Frances Zipp, President & CEO of Lachman Consultant Services, Inc., will also be present at the event. She will deliver both the opening and closing remarks, contribute to the "Visionary Panel: Addressing Challenges and Opportunities in the Biotechnology Industry through Collaborations with Contract Development & Manufacturing Organizations (CDMOs)," and take part in the Women in Pharma Roundtable Lunch.
Our team of experts will also be available throughout the conference, eager to connect and share their extensive industry knowledge and insights across a wide spectrum of subjects.