WEBINARS

 

Compliance Training Webinars for Regulated Industries

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

6 / Mar / 2023 - Monday

 

Business Writing for Financial Professionals

webinar-speaker   Phil Vassallo

webinar-time   90 Min

Product Id: 703262

This training on business writing will provide attendees tools and tips for effectively writing financial documents for diverse audiences. Learn best practices for getting an immediate response to any written document.

28 / Mar / 2023 - Tuesday

* Per Attendee $199

 

Combination Product Device Supplier Management Training

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706876

The U.S. FDA continues to increase its requirements for tighter control and management of vendors / suppliers / outsourcing. Combination products doubles the problems. And Covid 19 has compounded supply chain issues.

28 / Mar / 2023 - Tuesday

* Per Attendee $199

 

Process Simulation Testing for Aseptically Filled Products; An In-depth Examination of the Latest Product Sterility Assurance Levels Prescribed by GMPs

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706882

The objective of this live, interactive training webinar is to explore the role of media fills in assuring that manufactured product will retain the sterility assurance level prescribed by GMPs. It will review the issues regarding preparing media and setting up the “filtration train”, environmental monitoring, interruptions that may occur during the operation of the Clean Room (planned and unplanned) and the cleaning of the room and its equipment. Equipment used to monitor the equipment and personnel will also be reviewed along with gowning issues that periodically arise. The webinar will also discuss media failures and how to “work through” them. Because of the sensitivity and importance of media fills, this live, interactive training webinar is a MUST for anyone in your organization that is involved in aseptic filling in general and media fills, in particular.

30 / Mar / 2023 - Thursday

* Per Attendee $199

 

Facilities Management Training Course

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 706910

The purpose of this facilities management training course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.

31 / Mar / 2023 - Friday

* Per Attendee $199

 

How to Globally Register a Medical Device?

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706890

Attend this webinar if you are faced with the task of having to register a product worldwide and need to think about the most sensible and efficient way to do so. The correct order of the countries and the provision of the documents and what the differences are between the various technical dossiers of the countries are often decisive here. .

3 / Apr / 2023 - Monday

* Per Attendee $199

 

ICH Q7A GMPs for Active Pharmaceutical Ingredients Training Course

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706881

This live, interactive training webinar will examine a variety of the issues surrounding raw materials to include what materials should be tested and to what extent during Phase 1, 2 and 3. It will cover testing requirements as part of “Laboratory Controls” during each Phase and what laboratory testing may be optional until the ingredient moves to its next Phase. It will determine what options exist — even within a Phase 2 or Phase 3 testing framework. It will discuss compendial vs. non-compendial testing and how to respond when no method is available. Within the past several years the FDA has also issued a significant number of Warning Letters pertaining to 21 CFR 211.84 which involve management of raw/in-coming materials and which correspond to various sections within ICH Q7A. Please plan to attend the upcoming 90-minute Compliance OnLine webinar to learn how to avoid receiving this common citation and maintaining compliance with ICH Q7A. Please plan to bring an interdisciplinary group to obtain the most from this webinar.

4 / Apr / 2023 - Tuesday

* Per Attendee $199

 

The 6 Most Common Problems in FDA Software Validation and Verification

webinar-speaker   David Nettleton

webinar-time   120 Min

Product Id: 705582

This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.

4 / Apr / 2023 - Tuesday

* Per Attendee $249

 

Bloodborne Pathogens

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 706902

This course will teach you what the OSHA Bloodborne Pathogens Program requires to protect you and your Employees against obtaining a life-threatening disease.

5 / Apr / 2023 - Wednesday

* Per Attendee $149

 

Inspection and Audit Readiness Training for Medical Device Manufacturers

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706877

This webinar will focus on how to prepare domestic and foreign medical device manufacturers selling to the U.S. to recognize and prepare for FDA pre- and post-market inspections.

5 / Apr / 2023 - Wednesday

* Per Attendee $199

 

Employee Business Expense Reimbursement

webinar-speaker   Patrick A Haggerty

webinar-time   90 Min

Product Id: 706900

In this informative webinar, you will learn how to properly account for and report expense reimbursements and facilities provided to employees in compliance with IRS requirements. Discussion includes work from home expense reimbursement.

6 / Apr / 2023 - Thursday

* Per Attendee $149

 

Writing an Effective SAR Narrative

webinar-speaker   Doug Keipper

webinar-time   60 Min

Product Id: 702993

This BSA compliance training on Suspicious Activity Reporting (SAR) will provide details on how to prepare a SAR (Suspicious Activity Reporting) narrative that meets examiner scrutiny and provides necessary detail for law enforcement.

7 / Apr / 2023 - Friday

* Per Attendee $179

 

Increased Tariffs and Sanctions against China: How to Mitigate Your Exposure and be Compliant

webinar-speaker   Douglas Cohen

webinar-time   60 Min

Product Id: 706864

This webinar will teach you how to lawfully reduce your tariff costs. Also attendees will learn how to do this without large investments while also being compliant with all Customs laws.

10 / Apr / 2023 - Monday

* Per Attendee $149

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 704315

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

11 / Apr / 2023 - Tuesday

* Per Attendee $199

 

Change is Inevitable, Employee Acceptance is Not: Managing the Impact of Organizational Change on Employees

webinar-speaker   Maure Ann Metzger

webinar-time   60 Min

Product Id: 706895

This webinar will help participants understand how change impacts people, and why people resist change. You will also learn five powerful strategies for minimizing resistance and increasing engagement, and how to create and sustain a culture of change in their organization. This webinar will help organizations and leaders to be more strategic and successful with change efforts. The strategies included in the webinar will also benefit the people most impacted by change.

12 / Apr / 2023 - Wednesday

* Per Attendee $149

 

The Summary of Safety and Clinical Performance (SSCP)

webinar-speaker   Frank Stein

webinar-time   90 Min

Product Id: 706889

Attend this webinar to understand, what are the requirements of article 32 EU MDR 2017/745 for implantable devices and for class III devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance (SSCP). Your implementation needs smart ideas to reach the right level to pass the quality management audit and technical file audit by your notified body or authority inspection.

Recording Available

* Per Attendee $249

 

Stop Payments vs Unauthorized Entries – Compliance with the Nacha Operating Rules

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 704319

This training program will help find answers to many struggles with Stop Payments and Unauthorized Entries. These are still the number one issues in the exception processing of ACH transactions on a daily basis. This 90-minute session will definitely help clear things up on processing unauthorized, authorization revoked and stop payments!

Recording Available

* Per Attendee $249

 

De-Identification of PHI under HIPAA - Follow the Guidance to Avoid Penalties

webinar-speaker   Jim Sheldon-Dean

webinar-time   90 Min

Product Id: 706865

This session will review guidance from the HHS Office for Civil Rights (OCR) and from the National Institute of Standards and Technology (NIST) about how to properly de-identify health information. The various needs for de-identified information will be discussed and typical questions covered in the guidance will be discussed, in order to provide a sound, defensible basis for an organization’s decisions and processes surrounding de-identification of PHI. Attendees will be able to go forward with de-identification with greater confidence, and better sharing of information will be possible.

Recording Available

 

Faster Payments in Today's World – Details on the Different Types

webinar-speaker   Donna K Olheiser

webinar-time   60 Min

Product Id: 706871

There are so many ways to send money – FASTER! Payments such as, Same Day ACH (SDA), Real Time Payments (RTP), Push-to-Debit, Wire Transfers, and the pending arrival of FedNow. This 60-minute session will identify the different types and help you recognize the benefits and draw-backs of each one and the basics of how they work (with some examples).

Recording Available

 

Planning and Implementing an Ethics & Compliance Risk Assessment Program

webinar-speaker   Stanley Epstein

webinar-time   90 Min

Product Id: 706773

An ethics and compliance risk assessment is the foundation of an effective ethics and compliance risk management program. This detailed course provides a 12-stage framework that will help you complete your own ethics and compliance risk assessment. The 12 stages are divided into two components, the Planning Phase and the Implementation Phase. With a completed ethics and compliance risk assessment and armed with your findings and action plan, you will be equipped to develop and implement an effective ethics and compliance risk management program.

Recording Available

 

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