Site Preparation Strategy and Successful FDA Inspection
Yasamin Ameri
60 Min
Product Id: 703441
This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.
Selecting the Most Appropriate Predicate Device(S) for your 510(k) Application
Cheryl Wagoner
60 Min
Product Id: 703438
This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.
Data Management SOPs
Adam Ruskin
60 Min
Product Id: 703376
This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.
Fundamentals of SBA Lending: Documenting, Closing, and Funding the SBA Loan
Vincent DiCara
90 Min
Product Id: 703462
This webinar will explain the fundamentals of SBA lending and the two most used and popular SBA’s programs: the SBA 504 Program and the SBA 7a Program. Attendees will learn how to document SBA loans, as well as closing and funding SBA loans.
Current FMLA and ADA Issues for Managers
Max Muller
60 Min
Product Id: 703429
This webinar will address current HR issues regarding the FMLA and ADA. It will discuss the common mistakes that managers make when applying these laws and how to avoid them.
Equipment Requalification: What and When it is Really Required?
Jennifer Medlar
60 Min
Product Id: 703450
This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.
Foreign Corrupt Practices Act - Critical Issues and Best Practices
Andrea Ewart
90 Min
Product Id: 703167
This training on the Foreign Corrupt Practices Act will focus on the anti-bribery and accounting provisions of the FCPA and will explain the activities and conducts that are prohibited by the FCPA. Learn the best practices and strategies for avoiding criminal and administrative penalties for violating its provisions.
Issues - Terminations and Exits - Legal Compliance
Diana Chomichuk
60 Min
Product Id: 703428
This webinar will explain how to manage employee terminations and exits. Attendees will gain understanding and discover recommended best practices and techniques for ensuring compliance, fairness, and reasonable support during sensitive employee terminations and exits.
FAA Procedures for Transportation Workplace Drug and Alcohol Testing Programs
Butch Wilson
60 Min
Product Id: 703456
This webinar will discuss the required procedures for conducting workplace drug and alcohol testing for the federally regulated transportation industry. Attendees will learn how to ensure compliance with the FAA's Drug and Alcohol Testing Regulation.
Regulatory Records Primer: Decoding the Requirements for Medical Device and Pharmaceutical Manufacturers
Les Schnoll
90 Min
Product Id: 703433
This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.
Quality Systems Approach for Validation and Maintenance of a Global ERP System
James Carron
90 Min
Product Id: 703424
This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.
COSO 2013 Framework vs. ERM Framework: Implementation Challenges and Opportunities
Sonia Luna
90 Min
Product Id: 703415
This webinar will explain similarities and differences between COSO v ERM frameworks. Attendees will understand key advantages of using the ERM framework over the updated COSO 2013 model.
Adverse Event Reporting Requirements for Dietary Supplements and OTC Drugs
Mukesh Kumar
90 Min
Product Id: 703422
This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.
Effective Coaching for Sustainable Peak Performance
Gail Birks
60 Min
Product Id: 703425
This webinar will help you enhance your current strategies of coaching employees & teams for sustainable peak performance. You will be given that are designed for effective coaching, defining roles, measuring performance & implementing plans.
The New European Union Clinical Trials Regulation: An Analysis of the Key Changes and their Implications for Future Clinical Trials
Ciara Farrell,Elisabethann Wright
60 Min
Product Id: 703445
This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.
OSHA Refresher Course - Electrical Safety Compliance
Leo Muckerheide
90 Min
Product Id: 702424
This webinar will help you understand the applicable electrical safety practices in the workplace and review the responsibilities and requirements for a person qualified in the OSHA and National Fire Protection Association’s (NFPA) standards.
LDT including CDx; CLIA versus FDA's Authority
Abdel Halim
60 Min
Product Id: 703399
This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.
How to respond to GXP (GCP, GLP, GMP, GPV) Inspection and Audit Findings using Correction and Preventative Action (CAPA)
Laura Brown
60 Min
Product Id: 703160
This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).
Business Associate Agreements (BAA): Why the Pushback from Business Associates
Tom Dumez
60 Min
Product Id: 703397
This webinar will explain the requirements of the Omnibus Final Rule regarding Business Associate Agreements (BAA’s) including what it was, what it is now, and what it might be in the future. It will discuss responsibility, liability, indemnification, injunctive relief, and other topics that are causing, or may be causing, contention.
Understanding OSHA - Avoiding Citations and Preparing for the Unexpected
Paul Gogulski PE
90 Min
Product Id: 703419
This webinar will explain how to prepare for an unannounced OSHA inspection and avoid citations and fines. Attendees will learn how to effectively use Job Hazard Analysis (JHA) to prevent accidents in the workplace.