Full Day Virtual Seminar: Medical Device Process Validation - FDA Inspectors are Checking - Are You Prepared?
Daniel O Leary
6 hr
Product Id: 701649
This 6-hr training provides a detailed understanding of process validation for medical devices approach employing IQ, OQ, and PQ. Information includes preparation of protocols and reports, application of Statistical Process Control, concepts of Design of Experiments, using attribute sampling plans, and a discussion of GHTF document on process validation.
Food Allergen Labeling - Complying with FALCPA and FSMA
Katherine Giannamore
60 Min
Product Id: 702559
This webinar will provide information on food allergen labeling, the requirements set forth by the U.S. Food and Drug Administration (“FDA”) pursuant to the Food Allergen Labeling and Consumer Protection Act of 2004 (“FALCPA”). It will show how foods, including dietary supplements, must be labeled to comply with federal law and regulations, and illustrate how failure to adhere to these requirements frequently results in costly delays and recalls.
SOX Compliance: Accounts Receivable Risks and Controls
Chris Doxey
60 Min
Product Id: 702510
In this 60 minutes webinar, you can discover the in and out of accounts receivable risks and controls in compliant with SOX. The speaker brings vast knowledge and experience to guide you through with the know-how of accounts receivable process, fraud, weaknesses, deficiencies and the efficient ways to deal with them.
3-hr Virtual Seminar: South Korea - Navigating the South Korean Regulatory Compliance and Clinical Trial Environment
Robert J Russell
3 hrs
Product Id: 702153
This 3-hr training on South Korean regulatory compliance requirements for life science products will discuss about the regulatory structure, clinical trial requirements and the conduct of running clinical research in South Korea.
Safety Committees - How they Help with OSHA Compliance and Improve Safety
Don Dressler
60 Min
Product Id: 702463
This webinar will guide you in setting up a safety committee, defining its role, setting goals and evaluating them to measure its success.
Fundamentals of the Family and Medical Leave Act
Kenneth Sprang
60 Min
Product Id: 702517
The objective of the webinar is to present you with all-inclusive information on Federal Family and Medical Leave Act. Our leading expert will also help you learn addressing employee abuse, integration of the FMLA with your company’s leave programs, and other practical concerns that you may have.
OSHA Ergonomics Compliance - What Every Organization Needs to Know
Charissa Shaw
60 Min
Product Id: 702498
This webinar will cover the basics of OSHA ergonomics compliance and show you what to do, step-by-step, to ensure your ergonomics program is in compliance and the company is protected from citations, penalties, and enforcement actions from OSHA.
Non-inferiority Trials: Practical Issues and Current Regulatory Perspectives
Rita Hanover
60 Min
Product Id: 702476
This webinar will examine and highlight differences among non-inferiority (NI) trials, equivalence, and superiority study objectives and designs. It will also review current FDA guidance for NI clinical studies.
3-hr Virtual Seminar: OSHA National Emphasis Program (NEP) - Anhydrous Ammonia Refrigeration Specific Review
Bill Greulich
3 hrs
Product Id: 702354
This 3-hr virtual seminar will help you understand the requirements of OSHA PSM and NEP audit topics that have been interpreted and reviewed in the compliance guidelines as they might apply to an anhydrous ammonia refrigeration plant.
Interpreting FDA's New Guidance Document on Risk-based Monitoring
Moe Alsumidaie
60 Min
Product Id: 702485
This webinar will train you on interpreting FDA's new guidance document on risk-based monitoring. It will include a case study demonstration on how any biopharmaceutical, medical device, and CRO could leverage the applications of breakthrough techniques to implement risk-based monitoring.
Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond
Bob Michalik, JD, RAC Michalik
90 Min
Product Id: 702500
This 90-minute 510(K) training will provide practical tips and tools (templates) for preparing regulatory marketing submissions that will ensure swift clearance of your Class II and Class III medical devices.
When does GCP Non-compliance at an investigator site compromise a regulatory submission? To File Or Not To File - that is the question!
Stephen Schwartz
75 Min
Product Id: 702519
This webinar will help you manage the risks associated with GCP non-compliance at a pivotal investigator site. The training will follow a case-study approach to help you learn how to determine investigator non-compliance and guide you in deciding whether or not to file the efficacy study data in a regulatory application.
Adjusting your Compliance Program to Meet new FDA Requirements
Jason Mefford
60 Min
Product Id: 702509
This webinar will help you understand the new FDA requirements related to the FDA Food Safety Modernization Act (FSMA). You will learn how companies must change their compliance programs in order to meet these new requirements.
The Evolving Role of Internal Audit
Paul Gostelow
90 Min
Product Id: 702483
This 90-minute webinar examines the changing role of internal audit and how an organization can start to develop its internal resources to meet the new challenges that it faces in the current economic and regulatory environment.
Effective Training Practices for FDA Compliance
Dr. Ludwig Huber
75 Min
Product Id: 702513
This webinar will provide participants a good understanding of FDA requirements for training and provide recommendations for implementation.
Effective Use of Validation and Verification to Improve your Food Safety Management System
John Surak
60 Min
Product Id: 702458
This webinar will cover strategies to effectively use the proper validation and verification techniques to increase the effectiveness of a FSMS. It will show how any food or pharmaceutical company can properly use these techniques to ensure compliance with either ISO 22000 or ISO 9001.
International Credit and Debt Collection Challenges
Steven Gan
60 Min
Product Id: 702409
This webinar will discuss the credit risk management controls you need to have in place prior to doing business with a customer overseas and what collection and legal recourse you can take when a customer defaults on payment.
All about OSHA: Comprehensive 4 Courses Training for your organization
Kenneth S. Weinberg ,James T. Dufour,William Principe
6.5 hrs
Product Id: 702571
This 4 course OSHA training webinar will cover Compliance information (CA), Recordkeeping, Misconception and Hazard Communication. These training are chosen to provide you with the most important information on OSHA led by experienced speakers.
Finance Training Suite on IFRS, Foreign Corrupt Practices, FCPA, P2P Metrics and Travel Claim Fraud
Jon Groetzinger,Chris Doxey,Paul Gostelow,Mike Morley,Anne M. Marchetti
5.5 hrs
Product Id: 702572
This suite of finance training covers four courses – IFRS effect on SOX Control, IFRS vs GAAP and its adoption, FCPA, P2P Metrics and Travel Claim Fraud.
Finance Training Course: Reporting, Internal Control, Regulations and Being Compliant
Mike Morley,Bob Benoit,Dan Swanson,Peter Goldmann,Paul Messerschmidt
6 hrs
Product Id: 702570
A comprehensive expert-led intensive training course on all aspects of using International Financial Reporting Standards (IFRS), GAAP, Internal Control, Accounts Payable Fraud and Social Media for Finance (FINRA). You will be able to render decisions about these scenarios which is just one of the many goals of this Finance Training Course.