Compliance Training Webinars for Regulated Industries

This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.

This Food safety training will provide valuable guidance to management, supervision, and quality staff that are involved with record keeping for product and ingredient traceability and recall.

Both the U.S. FDA and EU's MDR expect documented risk-based equipment, process,systems and procedures development, integration and maintenance.

This contamination control training will focus on how to use the EM data appropriately as part of a contamination control plan and also discuss about Designing and Managing a Microbiological Monitoring Program.

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.

What are the rules regarding how you may contact a debtor? They are so complex and confusing! There are many issues involved, such as what questions you may and may not ask someone other than the debtor and restrictions on what you can leave in voicemail or send in an email, and the best ways to handle suspected deadbeats. What is the best practice for postings to open accounts when the debtor may file bankruptcy? Did you know that medical collections must be treated with more care than consumer collections? Learn the answers to all of these issues and your own questions when you attend this detailed presentation of the FDCPA.

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.

However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar identifies and describes ten keys that unleash the power of SPC.

The audience will take away a basic understanding of what the OSHA Recordkeeping Requirements are and learn to navigate the complexities in filling out the 2024 OSHA Recordkeeping Forms.

New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.

We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.

We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.

This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.

This webinar is focused on the Quality Management System' oversight of manufacturing and its documentation. What is required of a compliant system according to ISO 9001, 21 CFR 820 / ISO 13485, and 21 CFR 210 and 211 ..

Understanding Tokenization and its Supporting Technologies - A Guide to Converting Real-World Assets into Digital Tokens on Blockchain Web3 tokenization is a revolutionary concept that converts real-world assets or rights into digital tokens on a blockchain, allowing for secure and decentralized ownership, access, and value transfer. Unlike simple digital currencies, Web3 tokens can represent physical assets, intellectual property, or utility and governance rights within decentralized applications (dApps). This enables fractional ownership of assets, like real estate, and enhances investment opportunities without traditional intermediaries. As a key driver of the decentralized economy, Web3 tokenization is reshaping asset management and participation in digital ecosystems.

As payments continue to evolve, so does the ACH Network. In an effort to continually update the Nacha Operating Rules, Nacha had put out a RFC (Request for Comment) on adding a fourth window of opportunity for SDA (Same Day ACH) payments to allow more functionality with Same Day payments in all time zones.

This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.

Compliance with European Medical Device Regulation 2017/745 (MDR) is mandatory for all medical devices placed in the market in any member state of the European Union. It is of strategic importance for any medical device manufacturer to understand and effectively apply the MDR requirements to access this critical market.

Both the U.S. FDA and EU's MDR expect documented calibration and risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971