Preparing for a C-TPAT Revalidation
Beth Peterson
60 Min
Product Id: 700461
This C-TPAT Revalidation training will help certified C-TPAT members understand what’s entailed for a revalidation and will provide tools to ensure a smooth revalidation.
Processes for 510(k) Clearances for In Vitro Diagnostic/IVD Device Products via FDA-CDRH
Alfredo J Quattrone
60 Min
Product Id: 700442
This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.
Legally Managing Employee Absenteeism
Jodie-Beth Galos
60 Min
Product Id: 700409
This HR compliance will review the critical elements of the Americans with Disabilities Act, the Family Medical Leave Act, Workers Compensation as well as other relevant state leave laws and provide solutions to managing absenteeism fairly. There are few things as disruptive to operations as unexpected absences of employees. Many organizations have come to value dependability of attendance over other employee characteristics.
Process-Based and Metric-Driven Internal Audit Approach
Angelo Scangas
60 Min
Product Id: 700401
This Internal Audit Approach training/webinar is designed to enhance your understanding of process auditing techniques Using interactive examples and a case study.
Best Practices in 510(k) Submissions
William G Mclain
60 Min
Product Id: 700209
This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.
Validation Challenges for Bioassays
Dr. Wise Blackman
60 Min
Product Id: 700232
This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay
Training Requirements and Practices to Assure QSR and ISO Compliance
Jeff Kasoff
60 Min
Product Id: 700316
This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.
Five Steps in Conducting Audits - ISO 19011
Jayne Pilot
60 Min
Product Id: 700284
Pilot has provided training in auditing since 1995 using her Three Step System Approach for Auditing and her Five Steps in performing audits This presentation cover in simple terms the five steps to conduct audits and the working documents required. 1 - Initiating, 2 preparing, 3 Conducting - opening/closing meetings, collecting evidence, findings, 4 Audit reports, 5 Audit completions.
Virtual SOX Compliance
Bob Benoit
60 Min
Product Id: 700405
Virtual SOX is one of the first open doors to effective and efficient sox compliance pathway. Using technology and local administrative talent we can gather backup documents, scan, upload and observe access controls. The concept of performing a Section 404 effort completely remote requires us to have a very different paradigm shift.
GSA Schedule Compliance - What's important now?
Tomi Bryan
60 Min
Product Id: 700328
In this GSA compliance training we look back at the most notable GSA Schedule contractor violations of the year and how to keep those from happening to your company.
Management Controls needed for an effective QMS to meet FDA QSR and ISO 13485 regulations
Susan C Reilly
60 Min
Product Id: 700134
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.
Complaint Handling and Management: From Receipt to Trending
Jeff Kasoff
60 Min
Product Id: 700319
This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.
Quantitative Approach to User Requirements Risk Assessment
Vimarie Ortiz
60 Min
Product Id: 700390
This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.
GSA Schedule Recordkeeping - the 21 Documentation Libraries every Schedule contractor must have
Tomi Bryan
60 Min
Product Id: 700327
This GSA compliance training will provide valuable assistance to all GSA Schedule contractors and will review the 21 documentation libraries that every Schedule contractor should have.
Cleanroom Design, Certification & Classification
Nazia Dar
60 Min
Product Id: 700404
This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.
Project Manage Your Validation Project -- An Overview
Lawrence Mucha
60 Min
Product Id: 700367
This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements
An Overview of Design and Development Planning
Ellen Golds
60 Min
Product Id: 700380
This training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.
From CAPA to Capability: Shifting the Focus to Profitability
Barbara Johnson
60 Min
Product Id: 700377
This Quality training will help you look holistically at your quality systems and embrace a continuous improvement approach that will drive quantifiable business benefits. A quick review of your log of corrective and preventive actions can be quite revealing. Many executives have found that their past improvement initiatives only addressed problem areas regarding individual products.
CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process
Susan C Reilly
60 Min
Product Id: 700299
This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process
PET Container Stress Cracking - Mythology and Science
Stephen Zagarola
60 Min
Product Id: 700360
In this Packaging & Labeling training we take on what is probably P.E.T. greatest nemesis -- especially for those manufacturing and using P.E.T. Bottles in warm climates.