WEBINARS

 

Compliance Training Webinars for Regulated Industries

Validation for Medical Device Manufacturers - Master IQ, OQ, PQ

webinar-speaker   Susanne Manz

webinar-time   90 Min

Product Id: 706706

Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover the validation essentials for medical device manufacturers. You’ll 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’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.

15 / Jun / 2021 - Tuesday

 

Zero-Injury Workplace Culture vs. Safety Culture

webinar-speaker   Michael Aust

webinar-time   60 Min

Product Id: 704986

Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.

9 / Jul / 2021 - Friday

* Per Attendee $199

 

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.

13 / Jul / 2021 - Tuesday

* Per Attendee $249

 

Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention

webinar-speaker   Jeff Kasoff

webinar-time   60 Min

Product Id: 700986

This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.

13 / Jul / 2021 - Tuesday

* Per Attendee $199

 

Investigation of Out-of-Specification Test Results

webinar-speaker   Paul Larocque

webinar-time   90 Min

Product Id: 706638

Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.

13 / Jul / 2021 - Tuesday

* Per Attendee $249

 

Mobile Apps as Medical Devices

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 706721

The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.

14 / Jul / 2021 - Wednesday

* Per Attendee $199

 

Conducting Effective, Legally-Compliant Investigations of Harassment & Bullying Allegations

webinar-speaker   Diane L Dee

webinar-time   90 Min

Product Id: 705542

Missteps in handling sensitive employee issues could result in your organization writing a check with a lot of zeros on it. How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line. Cultural and generational diversity is changing the landscape of the US workforce. That diversity can become fuel for all types of litigation. Understanding how to effectively conduct workplace investigations can greatly reduce the chances of your organization being sued.

14 / Jul / 2021 - Wednesday

* Per Attendee $179

 

TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties

webinar-speaker   Miles Hutchinson

webinar-time   90 Min

Product Id: 703028

This IRS regulatory compliance training will explain the TIN matching system best practices to eliminate form 1099 reporting errors. It will also provide you the tools to effectively handle B- Notices in order to avoid fines and penalties.

15 / Jul / 2021 - Thursday

* Per Attendee $199

 

Holy Smoke! An Employer's Guide to Medical Marijuana in the Workplace

webinar-speaker   Janette Levey Frisch

webinar-time   90 Min

Product Id: 705703

In this webinar, we will explore the challenges employers now face in managing employee marijuana use. We will, also discuss applicable laws (both statutes and cases) addressing this subject, analyze recent court cases. The laws, of course vary by state. You will receive an overview of where many of the different states are currently holding with respect to medical and recreational marijuana and employer’s rights and obligations.

15 / Jul / 2021 - Thursday

* Per Attendee $179

 

CDD and its expansion by the AML Act of 2020

webinar-speaker   Jim George

webinar-time   60 Min

Product Id: 705602

The FinCEN has issued substantial new AML requirements focused on a major expansion of Know Your Customer into what is now Customer Due Diligence, CDD. This webinar will present various aspects of the requirements.

15 / Jul / 2021 - Thursday

* Per Attendee $199

 

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.

16 / Jul / 2021 - Friday

* Per Attendee $199

 

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.

19 / Jul / 2021 - Monday

* Per Attendee $229

 

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

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705583

In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.

19 / Jul / 2021 - Monday

* Per Attendee $229

 

Pharmaceutical Data Integrity

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706101

Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.

19 / Jul / 2021 - Monday

* Per Attendee $199

 

Medical Device Cybersecurity Risk Management Training

webinar-speaker   Frank Stein

webinar-time   3 Hrs

Product Id: 706560

This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.

20 / Jul / 2021 - Tuesday

* Per Attendee $329

 

Writing and Revising SOPs for Increased Operational Efficiency

webinar-speaker   Rob MacCuspie

webinar-time   60 Min

Product Id: 706214

This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.

Recording Available

* Per Attendee $299

 

Validation Master Plan - The Unwritten Requirements

webinar-speaker   John E Lincoln

webinar-time   60 Min

Product Id: 705877

This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Recording Available

* Per Attendee $299

 

On the Alert: Software License Audit Readiness

webinar-speaker   Robert Davis

webinar-time   60 Min

Product Id: 706722

Despite growing available information and training materials about the critical value of Software Asset Management, many organizations still find themselves unprepared for a software license compliance audit. A software license audit can cause severe disruption and takes time and resource away from business as usual. In this webinar, Dr. Davis will discuss the different approaches to achieving software license contracting compliance.

Recording Available

 

Human Error Reduction in GMP Manufacturing

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704107

This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.

Recording Available

* Per Attendee $299

 

Using Excel to Detect Fraud

webinar-speaker   Joe Weil

webinar-time   100 Min

Product Id: 705022

This webinar training pays for itself in terms of your firm's potential savings and detection of fraud. The training is designed to both prevent and detect fraud. We first teach you how to establish an administrative environment where fraud is less likely to occur. We’ll then examine Excel tools that are used by CPAs and Internal Auditors to detect fraud.

Recording Available

* Per Attendee $249

 

 

 

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