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4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions
Joy McElroy
4 hrs
Product Id: 704778
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
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Compliance with Canadian Quality Management System Regulatory Requirements
Edward Kimmelman
90 Min
Product Id: 704726
The training program will provide insight into complying with the key QMS requirements for organizations selling medical devices in Canada.
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Successful Device Submissions and Approvals - Key Elements
Charles H Paul
60 Min
Product Id: 704813
This Training will describe the basic requirements for medical device submissions. The topic will spotlight the differences and focus upon the required quality system elements that must be addressed. It will provide an overview of the FDA premarket and EU Medical Device Directives submissions processes and discuss how devices are classified.
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FDA's Medical Device Software Regulation
Casper Uldriks
90 Min
Product Id: 704749
This training program will focus on FDA software guidance. It will elaborate on applying current provisions that NIST (National Institute of Science and Technology) has put forth in recent reports that FDA will integrate into its regulatory oversight as well.
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Using an IQ / OQ / PQ Approach to Validating Medical Device Software
Mercedes Massana
60 Min
Product Id: 702117
This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation.
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How to Write Error Free and FDA Compliant Procedures
Ginette M Collazo
90 Min
Product Id: 704122
This training program will focus on the importance of procedures. Attendees will learn why people avoid procedures and understand common human errors and deviations related to the use of procedures.
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Effective CDISC Clinical Data Acceptance Testing and Compliance
Sunil Gupta
75 Min
Product Id: 704687
This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.
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Process Validation Guidance Requirements, FDA, EU Annex 15; Qualification and Validation
Joy McElroy
4 hrs
Product Id: 704737
This training program will illustrate how these two different concepts are integrated (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge. Attendees will learn if they exist independently of each other or do they complement each other to enhance, build and provide a product.
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UDI Implementation
Daniel O Leary
90 Min
Product Id: 703588
This webinar on UDI implementation will discuss the new requirements set by FDA for Unique Device Identification. Attendees will learn to overcome hurdles in implementing the new process and learn best practices too.
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Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process
Jeff Kasoff
60 Min
Product Id: 701786
This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices.
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Medical Device Complaints, MDR's and Recalls
John Chapman
60 Min
Product Id: 700196
This training program on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.
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An Easy to Implement Integrated Risk Management Approach Compliant with ISO 14971
Mercedes Massana
60 Min
Product Id: 701773
This integrated risk management training for medical devices will discuss how to incorporate risk management as per ISO 14971 guidelines in all phases of medical device development. It will highlight the documentation needed to support the decisions made as part of the risk management process.
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Protecting Your Intellectual Property Abroad
Douglas Cohen
60 Min
Product Id: 702972
IP piracy costs more than a loss in sales. If your brand loses value because it is seen as less exclusive or is confused with poor imitations this poses a long term threat to profitability. Re-establishing brand identity and company reputation is expensive if not impossible. This webinar will provide specific, practical steps to take to lessen this risk of loss.
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FDA Compliance and Laboratory Computer System Validation
Carolyn Troiano
60 Min
Product Id: 704660
Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.
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Standards and Their Role in Medical Device and Patient Safety
Lena Cordie Bancroft
90 Min
Product Id: 704654
This training program will explore the relationship of standards to medical device legal requirements. It will clarify the standards development process and discuss relationship of standards to patient safety.
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Preventing Recalls and Product Liability Lawsuits - Current Trends and Causes
Randall Goodden
60 Min
Product Id: 703080
This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.
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Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products
Angela Dunston
120 Min
Product Id: 704623
This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.
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Integrating Clinical Evaluation and Risk Management
Daniel O Leary
90 Min
Product Id: 701757
The webinar will discuss clinical evaluation, including the recommendations from MEDDEV 2.7-1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. The training program will also cover MEDDEV 2.12-2 Guidelines on Post Market Clinical Follow-Up. Risk management, following EN ISO 14971: 2012, requires a risk management plan that includes activities related to collection and review of relevant production and post-production information. In this program, attendees will look at some approaches to write a post-production collection and review plan.
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Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production
Carlos Rodriguez Garcia
60 Min
Product Id: 704248
The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.
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Quality Writing for Technical Communicators
Phil Vassallo
60 Min
Product Id: 704017
This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.