WEBINARS

 

Compliance Training Webinars for Regulated Industries

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Workplace Violence Prevention

webinar-speaker   Joe Keenan

webinar-time   60 Min

Product Id: 705522

This webinar will teach you how to get proactive and put programs in place to prevent a workplace violence episode and how to respond to an active shooter scenario. This training will discuss in detail the Do's and Don'ts in reference to workplace violence prevention.

Recording Available

* Per Attendee $179

 

Knowing your Post-Market Clinical Follow-up (PMCF)

webinar-speaker   Frank Stein

webinar-time   60 Min

Product Id: 706888

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in clinical post market surveillance into your current quality management system according to ISO 13485:2021. Your implementation needs smart ideas to reach the right level to pass the quality management audit by your notified body or authority inspection.

Recording Available

* Per Attendee $249

 

Useful Statistical Methods for Defining Product and Process Specifications - Part I

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 706897

This webinar covers useful and important statistical methods that assist scientists and engineers in the development of appropriate product and process specifications. Appropriate product specifications are critical to achieving adequate and reliable product performance.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* 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.

Recording Available

* 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.

Recording Available

* 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.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $249

 

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.

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

 

Writing High-Impact Executive Summaries

webinar-speaker   Phil Vassallo

webinar-time   90 Min

Product Id: 704127

This training program will help attendees approach the writing situation with a clear and useful strategy. It will include strategies to fuse the purpose of the summary with the issues that matter to your audience. Attendees will also learn to sort ideas to clarify key points and craft paragraphs that reinforce the intent of the executive summary.

Recording Available

* Per Attendee $249

 

Conducting Remote Medical Device QMS Audits Training

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706875

Remote QMS-CGMP compliance inspections are here to stay. Add it to your toolbox for vendor and remote site audits, especially for low to moderate risk companies.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $249

 

Medical Device Process Validation Training for Professionals

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701662

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, 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 $249

 

Medical Device Non-Product Software Validation Training

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706874

This presentation focuses on the verification and validation planning and execution of software, used in medical device manufacturing, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf), custom, and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. The focus is on the most recent issues the FDA has had in this area, and remediation approaches. Software considered: 1) Production / Test, and 2) QMS / 21 CFR Pt. 11, and 3) Cybersecurity / Networked systems. Examples will be demonstrated. Evaluation of the chief areas of FDA concerns will focus on actual and anticipated changes in emphasis based on the changing regulatory climate.

Recording Available

* Per Attendee $249

 

GMP Compliance for Quality Control and Contract Laboratories

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706869

This webinar will cover the requirements for laboratory controls under US GMP regulations, such as those relating to equipment calibration and preventive maintenance; sample chain of custody; good documentation practices; investigation of out of specification and out of trend results; analytical method validation; change control; impact of staffing levels and work flow patterns in the lab on GMP compliance; training and other issues.

Recording Available

* Per Attendee $249

 

US FDA Labeling Requirements for Medical Devices

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706873

The definition of labels is well defined and ususally well known; "labeling" not so well. Differing requirements for different applications can be confusing and are the subject of this webinar.

Recording Available

* Per Attendee $249

 

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.

Recording Available

* Per Attendee $299

 

Medical Device Change(s) and the 510(k)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701742

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

Recording Available

* Per Attendee $299

 

 

 

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