WEBINARS

 

Compliance Training Webinars for Regulated Industries

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).

10 / Mar / 2023 - Friday

* Per Attendee $199

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   90 Min

Product Id: 701687

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).

14 / Mar / 2023 - Tuesday

* 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!

21 / 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

 

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

 

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

 

USP <61>/<62> Microbiological Enumeration and Examination of Non-Sterile Products – Understanding the Current Standards for the Revised USP and Harmonized EP Microorganisms

webinar-speaker   Barry A Friedman

webinar-time   90 Min

Product Id: 706883

The objective of this live, interactive webinar is to explore the changes to these historic USP test methods, compare them to the new European Pharmacopoeia (EP), 2.6.12 Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests and 2.6.13 Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms, methodology and how it impacts the typical cGMP microbiological laboratory.

13 / Apr / 2023 - Thursday

* Per Attendee $199

 

Managing Risks in Combination Products and Drug Delivery Systems

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706878

This webinar will provide valuable guidance to regulated companies in development and implementation of Product Risk Management Planning, Implementation, and Use. There will be added focus on the special needs of combination products. Also increased focus on the often high risk considerations of drug delivery systems, with the recent increased concern posed by potential cybersecurity vulnerabilities. This webinar will expand this tool into R&D design control, training, marketing, validtion, root cause analysis, CAPA / fralure investigations, GMP auditing, and liability reduction. Regular use of a few simple but powerful tools in a Product Risk Management File and Review template can contribute greatly to reduction of product liability, company-wide cost reduction efforts, less chance of recalls, and an improved bottom line.

3 / May / 2023 - Wednesday

* Per Attendee $199

 

Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance

webinar-speaker   Barry A Friedman

webinar-time   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”.

11 / May / 2023 - Thursday

* Per Attendee $199

 

Usability Principles for Medical Devices: Interpreting and Implementing IEC 62366

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706879

This webinar will provide valuable guidance to regulated companies in development and implementation of Use Engineering / Human Factors Engineering using the 9 stage model in IEC 62366-1. IEC 62366-2 on recommended implementation considerations will be briefly considered, with the focus on IEC 62366-1, the basic methodology. the webinar willshow when and how these tools are incorporated into R&D design control, risk management, validation, root cause analysis, CAPA / falure investigations, GMP auditing, and liability reduction. Unlike risk management, use engineering may not always be necessary, depending upon the user interface under review. Use engineering is designed to reduce product risk, increase intuitive product use, reduce liability, and less chance of recalls.

6 / Jun / 2023 - Tuesday

* Per Attendee $199

 

Medical Devices Periodic Safety Update Report (PSUR)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706880

PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.

11 / Jul / 2023 - Tuesday

* Per Attendee $199

 

How To Get Paid in International Transactions: The Ins and Outs of Letters of Credit

webinar-speaker   Douglas Cohen

webinar-time   60 Min

Product Id: 706870

This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.

Recording Available

 

FDA Modernization and Restructuring of the SDLC for Computer System Validation (CSV) and Compliance

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706561

As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.

Recording Available

* Per Attendee $299

 

1099 & W-9 Update - Complying with IRS Information Reporting Guidelines

webinar-speaker   Miles Hutchinson

webinar-time   90 Min

Product Id: 703220

For years the IRS has struggled with the independent contractor and tax collection. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding the information reporting on taxpayers by payors – the 1099. This time-consuming reporting obligation can be streamlined in a number of ways. Join us to learn more…

Recording Available

* Per Attendee $249

 

Supervising a Human Error Free Environment: You can do a Lot More than you Think

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706861

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss why supervision is so important in reducing and preventing human error. Supervision approaches near root causes and root causes for supervision related errors and will address the main five elements to assure an error-free environment.

Recording Available

* Per Attendee $249

 

Good Laboratory Practices by Using The Quality Management System (QMS)

webinar-speaker   John Fetzer

webinar-time   4 Hrs

Product Id: 706858

This GLP quality system webinar provides a general overview of the Proposed Rule, a GLP QMS and its implementation, GAP analysis, Plan-Do-Check-Act cycle, process control and optimization theory and quality audits are utilized for the analysis of an existing QMS and the potential benefits, barriers steps to implementing an optimized GLP QMS.

Recording Available

* Per Attendee $399

 

Unauthorized Transactions – Reg E vs Nacha Operating Rules

webinar-speaker   Donna K Olheiser

webinar-time   90 Min

Product Id: 706856

Unauthorized transactions come in many different forms, when returning using Reg E or the Nacha Operating Rules can be confusing. Discussion will include what, why and when while processing unauthorized returns. The trainer will define the limits of liability and who is liable for what amount while providing some real-life scenarios. Details on the error resolution process with Reg E for consumer notification to the financial institution, research time involved, and the timing of providing provisional credit; included will be guidelines on the “what if” there is no error, and providing notice to consumer, and any overdraft protection relating to that provisional credit being reversed. Included will be outlining the ACH return process, when using the ACH network is appropriate, and paperwork/forms needed. Recent Rules changes affecting Nacha compliance when sending unauthorized ACH Returns using Return Reason Codes R10 vs. R11 is included.

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 $249

 

Transfer of Analytical Methods according to USP <1224>

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706036

In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.

Recording Available

* Per Attendee $299

 

 

 

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