Good morning.(Intro to topic and presenter)Although the discussion will include references to the pharmaceutical industry, the lessons learned and success are applicable to all industries and all functions of a company. PharmTech; 16 years QMS/Validation, as the needs of our clients changed, push for guidance of TnT, we evolved to address this is as well.Work with major pharma, food and medical device, FDA regulated industries, but we do take on projects with other industries that see value in our front end planning process.My background is in LT financial planning and Investment Banking. I’ve assisted startups, municipalities and established companies raise capital and advised them on how best to deploy it in their operations for business value and ROI. At PharmTech on Traceability initiatives, we do the same…we identify where additional business value and ROI can be found within your supply chain, operations and processes.As a disclaimer, we are technology agnostic. We are also solutions provider neutral. The clients needs and the infrastructure they have in place are what determines what the solution we recommend they implement.This will NOT be a Technical conversation (edge devices, GLN selection, integration with ERP) rather focused on ROI and Biz Value (Ken quote).
Going back to our roots 16 years ago, we built our name and separated ourselves by squeezing ROI and financial benefit out of projects that were only viewed as regulatory. In the Validation world we were like BASF, we didn’t make the process, we made the process better.
With most of our initial projects we aren’t going in asking them to let us in and spend millions on our services. We typically enter in on small projects and grow from there. We go in looking for a long term relationship as the value of our services become apparent.
Current projects in California, Georgia, Illinois & Texas</li></li></ul><li>Partnering Benefits<br />Leadership<br /> Subject Matter Experts<br /> Led remediation of CAPA initiatives<br /> FDA Audits<br /> Third Party Audits<br />Experience<br /> 16 Years in Pharmaceutical Manufacturing as a Validation Provider<br /> Created and Implemented Audit Programs<br /> (Policy, Master Schedule, Execution and Resolution)<br /> Nationwide access to resources<br />
Achieve Full Regulatory Compliance<br />FDA 483 and Warning Letter Action Plans and Remediation<br />Corrective and Preventative Action (CAPA) Systems<br />Methods & Process Validation<br />Auditing and Gap Analysis (GXP, ISO, QSIT)<br />Supplier Assessment, Management & Improvement<br />Clinical Operations<br />CFR parts 11, 210, 211, 820 and ISO 13485 and ISO 14971<br />
Turnkey Capabilities</li></li></ul><li>Why PharmTech?<br />Project Leadership & Innovation<br />Credentialed: 16 year track record in Pharmaceuticals<br /> Founded Traceability Solutions Group<br />Cost Effective: Lump Sum Proposal<br /> Budget and project clarity from day 1<br />We Live in Your Space with an emphasis on;<br />Facilities, compliance, equipment and process<br />History of delivering ROI <br /> We don’t talk about value, we find it!<br />
Technology: Areas of Focus<br />Software Validation<br />Process Automation and Optimization<br />Computer Systems Validation (CSV)<br />Documentation and Record Keeping<br />Workflow Management<br />Business Analytical Tools<br />Part II of Electronic Records and Electronic Signature Requirements<br />