Making the Connection between FSMA and GFSI Requirements
Miranda Peguese
90 Min
Product Id: 705061
This webinar will explore the complex relationship between GFSI and FSMA and will outline how GFSI certification can help manufacturers reach regulatory compliance.
Statistical Concepts of Process Validation
Daniel O Leary
90 Min
Product Id: 701630
This webinar will discuss the fundamental statistical concepts to perform an effective process validation. Attendees will learn best practices to comply with QSR and ISO 13485:2016 requirements for process validation.
The Latest in CLIA Compliance for Clinical Labs
Dennis Weissman
90 Min
Product Id: 705374
This webinar will cover in detail the regulatory requirements of Clinical Laboratory Improvement Amendments (CLIA). It will also discuss major lab quality standards such as facility administration, general laboratory systems, personnel qualifications & responsibilities, proficiency testing and more.
HR Technology: Proceed With Caution
Judith Bevis Langevin
60 Min
Product Id: 705471
This webinar will cover the legal risks associated with HR technology such as payroll, recruiting and selection, performance management, employee tracking and monitoring etc. It will also provide best practices to manage these risks.
Laboratory Accreditation and Quality Management Systems Part 1: Management Concerns
Michael Brodsky
90 Min
Product Id: 705298
This training program will cover the requirements of ISO/IEC 17025 laboratory accreditation standard. It will focus on management components of QMS including document control, quality system, service to customer, internal audits and much more.
Electronic Records and Signatures - 21 CFR Part 11: Basic Concepts
Angela Bazigos
90 Min
Product Id: 703738
This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.
NY State Procurement Overview
Kenneth Jones
90 Min
Product Id: 705462
This webinar will provide an overview of New York State Procurement rules and vendor selection requirements. Attendees will learn best practices to draft procurement documents and comply with NY State Government procurement process.
Risk Based Approach in cGMP - Quality Risk Management (QRM)
Shana Dressel
60 Min
Product Id: 705412
This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.
The Case Management Leader's Role in Auditing for Compliance: How to Know What You Don't Know?
Bev Cunningham
60 Min
Product Id: 705460
The webinar will focus on critical rules and regulations that are applicable to the case management department, optimal processes to meet these regulations and the auditing procedure to obtain results for meeting them.
It will assist the case management department leader(s) in identifying required elements of compliance that must be measured. Critical compliance metrics which must be audited and reported to the appropriate staff member or group(s) will be identified.
Employment Contracts Outside the United States
Matthew W Burr
60 Min
Product Id: 705381
This webinar on Employment Contracts Outside the United States furnishes you with answers to everything you need to know about contracts. It will also discuss several key factors such as concerns with these contracts, when to seek guidance, and variation in contracts.
MIPS-Reporting Requirements, Compliance with the Quality System and Financial Impact
Tina Colangelo
60 Min
Product Id: 705476
This webinar will cover Merit-based Incentive Payment System (MIPS) reporting requirements including the details of its four performance categories. Learn how to score the maximum amount of MIPS points to earn the highest Composite Performance Score (CPS).
Conflicts of Interest in Financial Services; Identify, Eliminate, Mitigate and Disclose
Lisa Marsden
60 Min
Product Id: 705466
Learn how best to identify, mitigate and make accurate disclosures of conflicts of interest.
FDA Inspections: What Regulations Expect
Joy McElroy
90 Min
Product Id: 705346
Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.
Vendor Due Diligence: The Cybersecurity Perspective
Rayleen M Pirnie
90 Min
Product Id: 704700
In most industries, you can contract away a responsibility or task, but not the liability of an attack or compliance expectations. This training program will examine key questions in case of a security breach. Whom will your customers hold liable? Who is going to get fined and possibly sued? At the end of the day, your organization will suffer the negative publicity, the reputation damage, and financial loss of the attack. This program will address vendor due diligence and security to better understand the risks your organization could face while outsourcing your business needs.
Managing Communication in a Crisis and Protecting Your Brand
Michael Barrio
60 Min
Product Id: 705448
This webinar will focus on the effective crisis communication strategies. Attendees will learn best practices to protect their organization’s brand in the time of crisis.
Effective and Proactive Strategic Risk Management - A Vital Element to Achieve Effective Enterprise-wide Governance, Risk Management and Compliance (GRC) Programs
Javier Kuong
120 Min
Product Id: 705407
Learn an effective approach to practice risk management process that is proactive, strategic and top-down in nature to anticipate, avoid and mitigate potential losses from threats and risks that are present in the real world regardless of any organization’s wishes.
HIPAA Compliance for Dental Practices
Jay Hodes
90 Min
Product Id: 705236
This webinar will provide a detail understanding on HIPAA Security & Privacy Rules and its entire HIPAA compliance process; from the start to ongoing requirements for dental practices. On completion of this training, attendees will learn how to create a culture of compliance in your dental practices.
ADA Obligations: Disability Discrimination and Reasonable Accommodation
Judith Bevis Langevin
60 Min
Product Id: 705464
Learn the basics of ADA compliance, receive practical guidance on the disability discrimination issues most likely to create workplace issues, and identify resources you can use when ADA problems arise.
New Customer Due Diligence Beneficial Owner Rule
Joe Soniat
60 Min
Product Id: 705221
FinCEN is issuing final rules under the Bank Secrecy Act to clarify and strengthen customer due diligence requirements for: banks; brokers or dealers in securities; mutual funds; and futures commission merchants and introducing brokers in commodities. The rules contain explicit customer due diligence requirements and include a new requirement to identify and verify the identity of beneficial owners of legal entity customers, subject to certain exclusions and exemptions. This training program will walk attendees through the new rules and how to implement them.
Pharmacokinetics of Oral Absorption
Leon Shargel
90 Min
Product Id: 705458
This webinar will discuss pharmacokinetic principles of systemic drug absorption and its applications to the development of oral dosage forms. It will also provide practical examples to show how pharmacokinetics of oral absorption can be applied to drug product development.