WEBINARS

 

Compliance Training Webinars for Regulated Industries

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How to conduct an effective BSA Audit

webinar-speaker   Justin Muscolino

webinar-time   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.

Recording Available

* Per Attendee $185

 

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   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.

Recording Available

* Per Attendee $249

 

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703831

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

Recording Available

* Per Attendee $249

 

Conducting an effective Regulatory Examination

webinar-speaker   Justin Muscolino

webinar-time   60 Min

Product Id: 706983

Are regulatory examinations keeping you up at night? In the world of financial institutions, staying ahead of the regulatory curve is more critical than ever.

Recording Available

* Per Attendee $249

 

US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702029

This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it’s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

Recording Available

* Per Attendee $249

 

GAMP Data Integrity 21 CFR Part 11 Training Course

webinar-speaker   Kelly Thomas

webinar-time   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.

Recording Available

* Per Attendee $249

 

The Complexity and Interplay Among ADAAA, FMLA, and Worker's Comp (WC) - How Do They Work Together, or Not?

webinar-speaker   Dr. Susan Strauss

webinar-time   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.

Recording Available

* Per Attendee $249

 

Finished Pharmaceuticals CGMPs

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $249

 

Good Clinical Practice (GCP) Basics for GMP Experts

webinar-speaker   David L Chesney

webinar-time   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.

Recording Available

* Per Attendee $249

 

NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 – Part 2

webinar-speaker   Donna K Olheiser

webinar-time   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.

Recording Available

* Per Attendee $199

 

FFIEC BSA/AML Examination Manual: What Compliance Officers Really Need to Know?

webinar-speaker   Doug Keipper

webinar-time   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.

Recording Available

* Per Attendee $249

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   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.

Recording Available

* Per Attendee $249

 

NEW Nacha Operating Rules Changes for 2024 PLUS Changes Coming in 2026 - Part 1

webinar-speaker   Donna K Olheiser

webinar-time   90 mins

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".

Recording Available

* Per Attendee $229

 

US FDA's Cybersecurity and NIST Framework Requirementsfor Networks

webinar-speaker   John E Lincoln

webinar-time   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. 

Recording Available

* Per Attendee $249

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Recording Available

* Per Attendee $219

 

ACH Government Payment Processing - Handling Death Notification Entries (DNEs) and Reclamations

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 704540

This 90-minute session will provide the details on what is different and how the Federal Government has adopted the NACHA Operating Rules and what the exceptions to those Rules incorporate for the Federal Government. You will learn what the Green Book is and how this valuable on-line tool will help you with processing DNE’s and Government Reclamations.

Recording Available

* Per Attendee $249

 

Assess Impact For Supplier Change Notices

webinar-speaker   Alan M Golden

webinar-time   60 Min

Product Id: 706344

This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.

Recording Available

* Per Attendee $249

 

The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706968

The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.

Recording Available

* Per Attendee $249

 

Quality Agreements and Their Role as Part of a Quality System

webinar-speaker   Michael Ferrante

webinar-time   90 Min

Product Id: 706966

This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.

Recording Available

* Per Attendee $249

 

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 702540

This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.

Recording Available

* Per Attendee $249

 

 

 

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