Medical Device Supply Chain and Manufacturing Regulatory Compliance Training - Live Webinars, Recordings & CDs

This 90-minute webinar will review FDA's draft regulations for UDI and describe the new requirements for labeling medical devices. It covers the new regulations in 21 CFR Part 830, the changes to Part 820, the Quality System Regulation; Part 801, Labeling; Part 803, Medical Device Reporting; Part 806 Corrections and Removals; and other regulations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).

This webinar will explain what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes so that they will not run afoul of the FDA during inspections

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

Fundamental requirements for process validation in both FDA QSR and ISO 13485. Learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.

This Medical device quality audits training review the process used by FDA to perform inspections of medical device manufacturers and will provide advice for quality and regulatory personnel that required providing information to an FDA inspector.

This JPAL (Japanese Pharmaceutical Affairs Law) QMS training/webinar will explore, in detail, the QMS requirements placed on the foreign manufacturer via Ministerial Ordinance 169, Ordinance 2 and Ordinance 179.

This Pharmaceutical compliance training will demonstrate how to implement an effective audit program for both manufacturing and the laboratory and the ability to maintain GMP/GLP/GCP compliance with all suppliers and/or vendors.

This ASTM E2500 training will review how these ASTM (American Society for Testing and Materials) and ICH (International Conference on Harmonization) approaches can simplify the qualification process. Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.

The process is critical for device manufacturers to effectively evaluate and select suppliers and subsequently implement agreements ensuring consistent material quality and/or services provided. This webinar will provide a valuable and informative overview and guidance to manufacturers, especially medical device companies that are preparing to establish or have established supplier/vendor management qualification programs.

Using a reliable process to meet current quality standards to determine the verifiable causes of problems. Root cause analysis is a systematic method to determine the causes of non-conformances. To meet current quality standards, medical device companies must use a reliable process to determine the verifiable causes of problems.

This webinar will provide valuable assistance to internal auditors, audit managers and personnel of regulated medical device or IVD companies. This presentation will provide an understanding of the tools of risk management and how to integrate risk management into an effective internal audit program.

The workshop will provide guidance on the roles and responsibilities of each functional area in the company and how they relate to each other. Each company must demonstrate full implementation of the quality system by providing appropriate training and re-training when necessary, for its employees.

Detailed analyses of the sections of the QSR design control regulations that have requirements not present in the ISO 13485:2003 standard. Many companies are confidant that their ISO 13485:2003 design control system is compliant to the Quality System Regulation, yet FDA conducts an inspection and FDA 483 design control cites are written and warning Letters, seizures or worse ensue.

This Management Controls Under QSR and ISO 13485 training/webinar will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system and quality plan, and of course all aspects of management reviews.

This Residual Risk and Risk Acceptability webinar/training in medical devices will discuss how to meet this requirement and also how to determine what disclosures of risk need to be made in the instructions for use of the medical device and Proper evaluation of overall residual risk and the acceptability of this risk.

This Device Manufacturing webinar provide a understanding of the GMP and Quality requirements for the design, manufacture, storage, distribution, and installation of Medical Devices including the requirements for complaint handling, and servicing.

This Six sigma training in Medical device will demonstrate the value of using DFSS principles in developing such devices by identifying critical design, production and distribution parameters that affect the performance of the finished device. Design for Six Sigma (DFSS) can be used to design, manufacture and sell high quality, defect-free, safe, effective devices that meet the intended use while also generating healthy profit margins for the company.

This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.