Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Dr. Afsaneh Motamed Khorasani
60 Min
Product Id: 705583
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.
Digital Payments 2024 – the future of payments
Stanley Epstein
120 Min
Product Id: 704753
This webinar examines the current state of the payments industry - from the complexity of the current payments landscape, the growing range of bank and non-bank participants, the ever-increasing range of payments methods, interfaces and systems, open banking, regulation and the future payments scene. We also look at how the COVID-19 pandemic has and will continue to affect payments.
The Unthinkable: Violence in Healthcare from Bullying to an Active Shooter
Dr. Susan Strauss
120 Min
Product Id: 704727
The healthcare environment creates a major challenge in the prevention and intervention of violence. The rate of injuries and illness from violence in the healthcare industry is more than three times greater than violence in all private industry. This training program will explore what makes violence in healthcare unique and its negative ramifications on quality patient care.
Sample Size Determination for Design Validation Activities
Steven Wachs
90 Min
Product Id: 705852
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)
Steven Wachs
75 Min
Product Id: 705020
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
GAMP Data Integrity 21 CFR Part 11 Training Course
Kelly Thomas
90 Min
Product Id: 706912
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.
The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?
Dr. Susan Strauss
90 Min
Product Id: 704959
The webinar training will address ADAAA, FMLA, and Worker’s Comp laws that HR is responsible for upholding. When the laws are not followed, it increases the liability for the organization and interferes with a fair and equitable work environment for employees.
Finished Pharmaceuticals CGMPs
John E Lincoln
90 Min
Product Id: 706990
This webinar is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of finished pharmaceuticals under an appropriate system for managing quality. It is also intended to help ensure that The final drug product meets the quality and purity characteristics that they purport, or are represented, to possess.
Good Clinical Practice (GCP) Basics for GMP Experts
David L Chesney
90 Min
Product Id: 706991
This webinar presents an introduction to fundamental GCP concepts for personnel who are experienced in GMP but new to the GCP topic. It is designed to help adapt principles learned in a GMP context to GCP operations, pointing out the similarities and differences between Quality Assurance management in each of these disciplines.
Conducting Your 2024 Annual ACH Rules Compliance Audit - a Step-by-Step Guide
Donna K Olheiser
90 Min
Product Id: 705082
The Nacha Operating Rules and Guidelines require that all participating depository financial institutions (ODFI & RDFI), Third Party Senders (TPS) and Third-Party Service Providers (TPSP) that provide ACH services to the RDFI or ODFI, conduct an annual ACH audit by December 31 of each year (Nacha Operating Rules, Article 1).
NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 – Part 2
Donna K Olheiser
90 Min
Product Id: 706981
Part 2 – Effective March 20, 2026, two Rule amendments (Fraud Monitoring – Phase 1) – monitoring for Faud (as part of a larger Risk Management package) intended to reduce the incidence of successful fraud attempts and improve the recovery of funds after frauds have occurred.
FFIEC BSA/AML Examination Manual: What Compliance Officers Really Need to Know?
Doug Keipper
60 Min
Product Id: 703792
This webinar will go through every section of the revised FFIEC Bank Secrecy Act/Anti-Money Laundering Examination Manual to highlight changes and areas where banks should review their internal policies, processes and procedures for compliance. Understanding these changes will keep you prepared and updated for your next BSA/AML examination.
Gaining and Re-establishing Control of Your Cleanroom
Joy McElroy
60 Min
Product Id: 705317
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
How to conduct an effective BSA Audit
Justin Muscolino
60 min
Product Id: 706979
BSA rules and regulations must be followed by financial institutions. Although financial institutions have been managing BSA operations in accordance with regulatory requirements, the shift to BSA audits has become increasingly important. Regulators look to the financial institution for confirmation and proof that BSA operations are being audited properly to ensure that BSA efforts are implemented and managed properly.
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Joy McElroy
120 Min
Product Id: 704531
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements
Roger Cowan
60 Min
Product Id: 703727
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 - Part 1
Donna K Olheiser
90 Min
Product Id: 706973
Part 1 -- NEW changes to the Nacha Operating Rules include "minor" Rules changes - effective June 21, 2024 (no major impact on operations but a must know to remain in compliance - by knowing the things they are clarifying in the minor Rule change topics). In addition, Risk Management Topics - effective Oct 1, 2024 (covering topics that were proposed before but now really happening) - such as "Expanded use of Return Reason Codes R06 and R17"; "funds availability exceptions" and "Unauthorized Return changes for the RDFI with timing of the WSUD and returning the unauthorized transaction".
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance
Barry A Friedman
90 Min
Product Id: 706884
The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.
Understanding and Preparing for FDA Pharmaceutical Inspections
Michael Ferrante
90 min
Product Id: 706965
This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.
US FDA's Cybersecurity and NIST Framework Requirementsfor Networks
John E Lincoln
90 Min
Product Id: 706971
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry.