WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Conducting Effective Quality Audits: Beyond Audit Checklists

webinar-speaker   Michael Ferrante

webinar-time   60 Min

Product Id: 703539

This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.

Recording Available

* Per Attendee $249

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   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.

Recording Available

* Per Attendee $249

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Recording Available

* Per Attendee $249

 

Installation and Qualification of the Packaging Lines

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706996

Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

Recording Available

* Per Attendee $249

 

Process for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit

webinar-speaker   Marna Steuart

webinar-time   75 min

Product Id: 706219

Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.

Recording Available

* Per Attendee $249

 

CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers

webinar-speaker   Roger Cowan

webinar-time   60 min

Product Id: 703476

This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.

Recording Available

* Per Attendee $249

 

Supply Chain and Product Compliance Using RoHS, REACH, and Conflict Minerals

webinar-speaker   Kelly Eisenhardt

webinar-time   60 Min

Product Id: 703871

This training program will offer an in-depth look at three important product regulations focused on materials compliance and ethical sourcing, along with the tools and policies needed to implement them.

Recording Available

* Per Attendee $249

 

Preapproval Inspection and Submission to the FDA

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706998

This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.

Recording Available

* Per Attendee $249

 

Supplier Management with the new Medical Device Regulation EU MDR 745/2017

webinar-speaker   Frank Stein

webinar-time   60 Min

Product Id: 706068

In this webinar, learn how to implement the changes required by the new regulation EU MDR 745/2017 in your current quality management system in a simple and quick way. The information in this course is vital to your passing the Quality Management Audit by your certification company or notified body.

Recording Available

* Per Attendee $229

 

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

 

 

 

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