IT & Data
Blockchain Technology for the Life Sciences: A Comprehensive Primer0 Available
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.
The MHRA Data Integrity Guidance Clarified: What it Means for Industry & Patients(2)0 Available
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.
Data Integrity: Why Not Identifying Repeat Defects In Your Data Is Killing Your Performance0 Available
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.
Key Elements of Pharmaceutical Serialization and Track & Trace Systems0 Available
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.
Developing a Part 11 Compliance Plan in Clinical Research0 Available
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.
Mock Regulatory Inspections: How to Get the Best Bang for Your Buck
Investing in a Regulatory Mock Inspection (Mock) exercise is a trending industry inspection readiness approach. Execution of a Mock based on lessons learned from industry will ensure that your inspection readiness exercise accurately identifies gaps that are truly specific to your organization, providing the most bang for your buck.
Note to File 101: Critical Steps for When – And When Not To – Engage in NTFs
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.
Responding to Clinical Observations: Developing Robust Audit & Inspection CAPAs
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.
The EU General Data Protection Regulation (GDPR): What US Pharma/Biotech Companies Need to Know to Comply
The EU General Data Protection Regulation (GDPR) takes effect on 25 May 2018, bringing new challenges for US companies collecting and managing data on EU citizens. In recent years, the pharmaceutical and biotech industries have been hyper-diligent in protecting personal information of subjects involved in clinical research as well as post-marketing activities. We have redacted, encoded, and safeguarded in what seems every way possible. But now there is more! Companies outside the EU that are managing the private data of EU citizens will be required to follow the GDPR. Don’t get caught off guard! Join this live webinar to identify how the GDPR will impact your company, and how you can best strategize and execute solutions that will safeguard not only your patients but your employees and company too.