WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Non Resident Alien Payee (1042-S, W-8) - How to Handle the Information Reporting and Backup Withholding Requirements of the IRS

webinar-speaker   Miles Hutchinson

webinar-time   120 Min

Product Id: 703855

In this training program attendees will learn how to manage nonresident alien payee' tax issues in compliance with IRS information reporting and backup withholding requirements for NRAs. Also attendees will learn the five variations of forms W-8 including the new W-8BEN-E just released in Q1-2014. It will help attendees establish which W-8 to provide NRAs working for them.

Recording Available

* Per Attendee $299

 

CGMP controlled Raw Materials

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 705148

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.

Recording Available

* Per Attendee $229

 

Purchasing Cards: Overcoming Risks and Creating an Effective Program

webinar-speaker   Brian G Rosenberg

webinar-time   60 Min

Product Id: 704467

This training program will detail the components of a successful purchasing card program. It will also discuss implementing proper purchasing card controls, types of risk including fraud and misuse, auditing techniques, and more.

Recording Available

* Per Attendee $249

 

Key Ratio Analysis - Calculating and Interpreting the Numbers Correctly

webinar-speaker   David L Osburn

webinar-time   90 Min

Product Id: 704967

This training program will provide financial professionals guidance on key ratio analysis . It will also detail a five-step analysis plan to calculate the key ratios covering liquidity, activity, leverage, operating performance, and cash flow analysis.

Recording Available

* Per Attendee $229

 

Building a Strategic HR Department: Keep Your Job by Earning a Place at the Table

webinar-speaker   Matthew W Burr

webinar-time   60 Min

Product Id: 700639

In this webinar you will learn the tools of strategic thought and of creating a department that delivers real, measurable value.

Recording Available

* Per Attendee $229

 

Handling Sensitive Dress Code Issues without Getting Sued

webinar-speaker   Greg Chartier

webinar-time   90 Min

Product Id: 701702

Attend this Webinar to understand how to implement/change a dress code policy or how to make process so as to spend less time on dress-code-related problems.

Recording Available

* Per Attendee $249

 

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704659

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Recording Available

* Per Attendee $299

 

HR Investigations: Conducting Workplace Misconduct Interviews

webinar-speaker   Matthew W Burr

webinar-time   60 Min

Product Id: 700418

One of the most challenging tasks for any HR Professional or manager is investigating workplace misconduct. In this session participants will learn how to conduct such investigations & structure questions to get answers during the investigation process.

Recording Available

* Per Attendee $229

 

The Importance of Packaging and Labeling in Pharmaceutical Product Development

webinar-speaker   Michael Esposito

webinar-time   60 Min

Product Id: 706063

Packaging and labeling is often underestimated in the planning phases of pharmaceutical product development. This leads to unnecessary increases in cycle time, costly errors, and delays in product availability, or product recalls due to noncompliance. This webinar will help you succeed in pharmaceutical product launch by exploring its importance right from the conception of a product, its realization and distribution.

Recording Available

* Per Attendee $299

 

Introduction to European Good Pharmacovigilance Practices: 4-hr Virtual Seminar

webinar-speaker   Miranda Dollen

webinar-time   4 Hrs

Product Id: 706466

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide a robust introduction to Good Pharmacovigilance Practice (GVP) in the European Economic Area, reviewing all modules of the Guidelines on GVP published by the European Medicines Agency.

Recording Available

* Per Attendee $499

 

Best Practice Case Management Roles and Functions: How to Optimize RN and Social Worker Skill Sets

webinar-speaker   Toni Cesta

webinar-time   60 Min

Product Id: 705419

This webinar will discuss the standards of practice defined for social worker and nurse case managers and how it is applied to the contemporary roles and in turn how it can be applied to the everyday functions and activities social workers and nurses perform to complete their job. It will cover the various roles such as Patient flow, utilization & resource management, denial management, variance tracking, Transitional and discharge planning, Quality Management, Psychosocial assessment and counseling.

Recording Available

* Per Attendee $249

 

Process Validation Requirements for FDA's Quality System Regulation

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706753

Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the validation essentials for medical device manufacturers. You will learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We will cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

Recording Available

* Per Attendee $299

 

Access Point Case Management: Managing the Two-Midnight Rule via Your Routes of Entry

webinar-speaker   Toni Cesta

webinar-time   60 Min

Product Id: 706045

This case management webinar will explore how an initial assessment and clinical review can better ensure that patient is placed in the correct setting right from the get-go which is a very unique role played by ED and admitting office, transfer center case managers and social workers. The 2 midnight rule and the part that case management plays in managing it will also be reviewed. It will give idea about reducing the use of Condition Code 44 or self-denials when patients get admitted to the incorrect level.

Recording Available

* Per Attendee $249

 

Implementing a Quality Management System

webinar-speaker   Kelly Thomas

webinar-time   90 Min

Product Id: 705971

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 $249

 

21 CFR Part 111 - FDA Inspections for Dietary Supplements - How to Prepare

webinar-speaker   Andy Swenson

webinar-time   60 Min

Product Id: 706752

cGMP compliance for dietary supplements is mandated by FDA regulation 21 CFR part 111, which stipulates that anybody who produces, packages, labels, or holds a dietary supplement must create and implement current Good Manufacturing Practices (cGMPs) to ensure the supplement's quality. An FDA inspection is always imminent in a regulated industry. Their causes vary from receiving unknown SAERs to a scheduled visit. Regardless of the cause, the result is the same: THE FDA IS COMING.

Recording Available

* Per Attendee $299

 

How to Survive a DEA Inspection - Veterinary Medicine and Controlled Substances

webinar-speaker   Carlos M Aquino

webinar-time   90 Min

Product Id: 704885

This webinar will discuss federal laws on administering and dispensing veterinary medicine, penalties for non-compliance, DEA required records and effective methods to prevent unauthorized use of controlled substances.

Recording Available

* Per Attendee $249

 

Implementing Operational Risk Management in Foreign Exchange Activities

webinar-speaker   Stanley Epstein

webinar-time   90 Min

Product Id: 704115

This webinar seeks to provide a solid foundation to all parties involved in foreign exchange activities whether at executive, marketing, audit or operational levels into how the actual trading processes work, what the risks are and how these can be mitigated by using clearly defined standards of best practice.

Recording Available

* Per Attendee $249

 

Design Control Essentials for Medical Devices - Including Differences between ISO13485:2016 and FDA QSR

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706751

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.

Recording Available

 

Medical Device Software Development Under IEC 62304

webinar-speaker   Don Hurd

webinar-time   60 Min

Product Id: 706744

ANSI/AAMI/IEC 62304 is a Recognized Consensus Standard by the US FDA and a harmonized standard in the EU. This means that compliance to it provides a presumption of conformity to the requirements within those jurisdictions. Not complying with the standard has shown to lead to longer regulatory review times and frequent rejections.

Recording Available

* Per Attendee $299

 

How to Conduct Successful Supplier Audits

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704499

This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Recording Available

* Per Attendee $249

 

 

 

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