Overview of Changes in ISO 13485: 2016
Lena Cordie Bancroft
60 Min
Product Id: 704756
This training program will discuss changes from ISO 13485: 2003 to ISO 13485: 2016. Attendees will learn how to apply additional supplier controls and understand how improvement and corrective action clauses are strengthened.
How to Design and Implement a Dynamic Control Plan
William Levinson
90 Min
Product Id: 705171
Learn how the FMEA and control plan can be combined to create a dynamic control plan, a living document that helps to drive continual improvement.
How Create a Value-added cGMP/ISO 13485 Internal/Supplier Auditing System
Betty Lane
60 Min
Product Id: 705165
This webinar will cover creating of a value-added an internal and supplier auditing program for compliance to FDA and ISO 13485 internal auditing requirements. It will include how to set up and manage the auditing system, as well as how to conduct audits, and document the results and any nonconformities. It will discuss the value of a good auditing program.
Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012
Daniel O Leary
90 Min
Product Id: 703752
Medical device manufacturers need systems to implement regulatory requirements (meeting customer requirements and handling regulatory complaints) as well as a business processes to determine customer satisfaction. While the three systems are related, each serves a different purpose. You will learn how to implement a customer satisfaction process to complete theses three important aspects.
What You Should Know About Export Requirements for FDA Regulated Products from US to Foreign Countries
Rossano V Gerald
60 Min
Product Id: 705186
When exporting outside the U.S., exporters must consider the Food and Drug Administration (FDA) provisions as it helps them understand what documents and procedures are needed in coordination with the transaction process. This training program will provide an in-depth explanation of FDA-regulated products that are exported from the United States to foreign countries. Also, it will address what export documentation must be used in the transportation of FDA-regulated products.
GMP Training Practices to ensure Regulatory Compliance
Henry Urbach
90 Min
Product Id: 705077
By attending this webinar, you will gain a better understanding of the regulatory expectations for an effective and GMP-compliant training system. In this webinar your instructor will share with you what he has learned over the past decade of developing and delivering effective GMP training programs as well as from his 25 plus years of working in the Life Science industries.
MDR Program conforming to New FDA Guidance
Edwin Waldbusser
60 Min
Product Id: 705149
FDA, in November 2016, issued a Guidance explaining and clarifying the existing MDR regulation. Many of the details of the MDR regulation were unclear and ambiguous and resulted in nonconformances. This new Guidance attempts to eliminate confusion.
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
Joy McElroy
90 Min
Product Id: 704306
This 90-minute training program is designed for people tasked with performing external audits for their organizations. It is also for those tasked with developing, maintaining and/or improving programs for manufacturing facilities. This includes individuals that have quality management system responsibilities for making general improvements in their organization’s performance specifically related to equipment, processes and documentation.
3-Hour Virtual Training: Lean Leadership, Quality and the Customer
Charles H Paul
180 Min
Product Id: 705109
Lean is not a quick fix for doing more with less and doing it in half the time – it is not something you undertake to realize short-term improvements – it is on the other hand, a new way of thinking about your business and a new way of executing business activities. This virtual training and the others in the series will lead you through the journey of lean from its inception through complete implementation.
Contamination Control in Pharmaceutical, Biotech and Medical Device Cleanroom
Jim Polarine
90 Min
Product Id: 705078
This 90-minute webinar will cover general considerations for microbial control for non-sterile manufacturing areas, including attributes of an effective cleaning and disinfection program. Points to consider specifically aimed at oral solid dose (OSD) manufacturers will also be presented, including cleaning and disinfection of both product contact and non-product contact surfaces.
Linear Regression Analysis for Medical Device Manufacturing
Daniel O Leary
90 Min
Product Id: 705108
Analyzing processes to understand their operation and implementing improvement is a necessary element in any quality system, but is especially important in medical devices. One of the more important tools is linear regression. Using Excel, you can get the information you need for process improvement.
Introduction to FDA and EU Medical Device Submission
Charles H Paul
60 Min
Product Id: 705065
This webinar will overview each critical aspect of the FDA submissions process to include 510(k) and PMA) and contrast those key steps to those of the EU Medical Device Directives Submissions process.
Performing an Effective Out-of-Specification Result Investigation
Charity Ogunsanya
90 Min
Product Id: 705064
This webinar will provide the basic understanding of how to conduct a compliant and effective out-of-specification (OOS) result investigation which is critical in preventing product recalls, voluntary and involuntary plant shut down, and FDA 483 findings or warning letter. It will also provide a basic mainframe for the Quality Assurance unit in the final disposition of the affected finished product as well as provide guidance for the different types of OOS investigational systems.
Subcontractor auditing (cGMP/Pharma/Med device industries)
Jan Warner
90 Min
Product Id: 705063
This course will describe the basic principles and requirements for building a supplier audit program. This webinar will provide a framework on which to build your subcontractor auditing program.
Understanding Attribute Acceptance Sampling including Z1.4 and c=0 Plans
Daniel O Leary
90 Min
Product Id: 701388
This webinar provides the tools needed to understand and implement acceptance sampling. It explains the basis for sampling plans, the binomial distribution, and uses it to understand the sampling plan’s performance using the operating characteristic (OC) curve.
Reimbursement Requirements for Designing Innovative Devices
Tom Kramer
60 Min
Product Id: 704625
This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.
How to prepare a 510(k) FDA Submission
Edwin Waldbusser
60 Min
Product Id: 705024
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.
Audits - Seven reasons they don't work
Susanne Manz
90 Min
Product Id: 705042
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.
Moving FDA Boundaries for Direct-to-Consumer Advertising
Casper Uldriks
90 Min
Product Id: 705033
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.
Basic Concepts of Sterility Assurance
Mark Seybold
90 Min
Product Id: 705046
This course will provide a foundation for developing your technical skills related to sterility assurance.