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

This medical device process validation training will use recent warning letters to explain the regulatory requirements for process validation and what FDA Investigators look for. It will cover process validation components (IQ, OQ, and PQ), and the content of protocols and reports.

This webinar will discuss the use of Lean Six Sigma methodology for product complaint investigations and offer a standardized approach for FDA regulated life science companies to follow whenever product complaint investigations are needed.

This 90-minute webinar on personnel practices and microbial control in Pharmaceutical, Biotech, and Medical Device manufacturing will cover effective ways to train personnel on gowning and personnel practices in cleanroom operations to limit contamination. This webinar will also address controlling microorganisms on process equipment and product contact surfaces.

This webinar will provide processes and procedures to all medical device companies that are thinking of transferring equipment, molds, dies, systems and processes to contract manufacturers. It will follow a recent successful case study in the medical industry.

This 90-minute webinar will discuss the current good manufacturing practices (cGMPs) for medical devices and in vitro diagnostic devices.

This 90-minute webinar will discuss the new FDA "Global Engagement" Initiative for new areas for heightened CGMP compliance from U. S. FDA-regulated companies and their global partners. It will cover areas for increased awareness, focus, and remediation, and the approaches that are now mandated.

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.

This cGMP webinar for medical device companies will focus on recent manufacturing lapses that have resulted in major recalls, multi-million dollar fines and some criminal charges. It will analyze why they happened and show how to prevent it.

In this medical device training on Importing and Exporting learn and understand the import and export process for unapproved and approved medical devices and the documentation process involved. Examine the import and export requirements and ensuring compliance success.

Attendees will receive a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. You will learn the information to include in the protocols and reports, the role of Statistical Process Control (SPC), using Design of Experiments (DOE), attribute sampling plans as a verification method, and a discussion of the GHTF document on process validation.

Understanding the GHTF guidance document is particularly important, since FDA (CDRH) plans to issue it as a guidance document in FY2011.

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.

This presentation will discuss the differences between qualifications and validations as they apply to shipping and packaging. The objective of a shipping qualification program is to verify that product can be shipped throughout the supply chain within required temperature ranges and without damage. To accomplish this companies must conduct operational and performance qualifications for their shipping configurations. The operational qualifications consisted of temperature mapping of test loads that are challenged with “worst case” temperature profiles under controlled laboratory conditions. The performance qualifications were performed concurrent with actual product shipments.

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 Corrective and Preventive Action (CAPA) webinar will teach how the risk based approaches be implemented under CAPA.

This webinar will provide valuable assistance to all regulated medical device companies who implement internal audit programs to comply with US and international regulations. This presentation will provide an understanding of how to integrate US, Canadian, European and Japanese regulations into an effectively documented and implemented internal audit program.