IT & Data Integrity for Pharma - Life Science Training Institute - LSTI

IT & Data Integrity for Pharma

There is nothing more important than companies maintaining data integrity. LSTI designs engaging data integrity courses for the pharmaceutical, life science, biotech and med devices industry.

As the saying goes, “if you didn’t write it down, it didn’t happen.” Being able to produce, process and publish accurate data ensures you won’t have issues with the FDA or other regulatory authorities.

The Life Science Training Institute creates live and on-demand training solutions for individuals and organizations in life sciences who are passionate about data integrity.

Our trainers are industry subject matter experts (SMEs) who average over 20 years of life science and pharmaceutical experience.

Browse our IT and data training courses below.

How to Prepare for FDA Guidance on Computer Software Assurance (CSA) in 2021 – A Two Part Primer

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Kathleen Warner

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This course provides an introduction to FDA’s new guidance on computer software assurance (CSA). This guidance is planned for release in February 2021. In preparation for its release, the course will discuss the who, why and what you will need to know to transition from traditional computer system validation (CSV) to CSA.

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Remote Auditing for GMP Compliance During COVID-19: Challenges and Opportunities

Mark Allen Durivage

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Good Manufacturing Practice (GMP) audits can be difficult under normal circumstances, but especially under mandated quarantine periods like the current COVID-19 crisis. Remote audits allow an organization a viable alternative to ensure continued compliance with GMP by leveraging modern technologies and best practices. This course will show you how to stay compliant while fulfilling audit responsibilities remotely.

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The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients

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In March of 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) released the “‘GXP’ Data Integrity Guidance and Definitions” guidance document, which outlined the agency’s thinking on data integrity best practices. In October of 2018, FDA and MHRA held a joint GCP (Good Clinical Practices) Data Integrity Workshop, where the agencies clarified their expectations for data integrity in clinical studies and identified key risk areas using case studies and agency observations. This course will give you a baseline for data integrity requirements, and overlay lessons learned from the FDA/MHRA workshop.

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Blockchain Technology for the Life Sciences: A Comprehensive Primer

Brooke L. Casselberry

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This course will explore areas within the life sciences where early adoption is a possibility. A vendor-neutral review of current Blockchain software platforms and their potential fit within your organization will be provided. Finally, you will receive instruction on how to identify and execute the steps necessary for determining if Blockchain is applicable to your function within your organization.

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Developing a Part 11 Compliance Plan in Clinical Research

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This course will describe considerations for developing a plan for Part 11 compliance that prioritizes activities based on risk and importance for organizations involved in clinical research. Participants will learn how to identify which computing systems and service providers fall under Part 11, what SOPs they’ll need, and activities that should be conducted for their current systems.

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Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs

Penelope Przekop, MSQA, RQAP-GCP

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Pharmaceutical and Biotech Clinical R&D and Pharmacovigilance (PV) Subject Matter Experts (SMEs) are often in the hot seat during internal audits and regulatory inspections. Diligent, proactive companies provide various levels of inspection readiness for many employees, particularly those in middle management. The top inspection readiness priority is to avoid observations by preparing on various levels. This is great! However, audits and inspections do result in observations for many companies. With the increasing number of life sciences companies – and vendors that support them – training on how to develop and write an appropriate Corrective and Preventative Action Plans (CAPAs) is critical. Don’t find yourself beautifully prepared for your audit or inspection, yet unprepared for the aftermath. Join this webinar to learn best practices for preparation.

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Note to File 101: Critical Steps for When, and When Not To, Engage in NTFs

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How many times have you seen or heard this phrase? Perhaps it came in an email, echoed out of the conference room phone, or maybe you’ve even said it yourself? The intent of the note to file (NTF) is to clarify an irregularity in trial documentation or conduct, but when used too frequently or inappropriately, NTFs can highlight unresolved problems, add confusing or extraneous information, or take the place of necessary corrective action.

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Key Elements of Pharmaceutical Serialization and Track & Trace Systems

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Serialization and global track and trace requirements are now a reality. Compliance deadlines are fast approaching, and even the best laid plans are not sufficient for “go live.” This interactive session will provide critical information to keep your programs efficient and compliant, plus provide valuable job aids to get you started.

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Data Integrity: Why Not Identifying Repeat Defects In Your Data Is Killing Your Performance

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One of the biggest problems across all businesses, regardless of industry, is the issue of having repeat defects and errors occurring with data, and not being able to discern them. This session will show you how to identify current and potential data defects, and implement programs that will prevent and/or fix those risks.

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Introduction to Biostatistics: 2-Sample Tests and ANOVA

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In this session, you will develop the tools to set-up your hypotheses, identify the correct test to use, complete the test, and make your decision on the hypothesis in question. The course will show you how to translate your statistical answer into one that makes sense in the real world.

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HIPAA & Source Data Access: Dispelling the Myths

Sandra “SAM” Sather

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This course will help you navigate confusing HIPAA requirements and provide solutions to ensure patient data security. Through instruction and value-added documentation, you will walk away with actionable knowledge to keep your efforts compliant, and have the ability to separate fact and fiction.

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Introduction to Biostatistics: Hypothesis Testing

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This session will give you the tools to set-up your hypotheses, identify the correct test to use, complete the test, and make your decision on the hypothesis in question. Additionally, the course will aid you in turning your statistical data into an answer that will make sense in the “real world.”

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Introduction to Biostatistics: Collecting and Summarizing Data

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This session will give you the tools to interpret data, detect errors, and help you organize your data in an easy to understand format. This course will give you a foundation in biostatistics by detailing numerical summaries like mean, median, mode, variance, standard deviation, range, interquartile range (IQR), and coefficient of variation (CV).

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Using FMEA For Risk-Based Approach To Computer Systems Validation

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Professionals who attend this training will be equipped to present FMEA as a tool for scoping computer systems validation efforts to ensure that resources are focused on the most critical areas of risk.

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