Good Deviation Practice: What You Need to Know
John R Godshalk
60 Min
Product Id: 705293
This webinar explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.
The IRS Audit Process - Preparing for and Resolving an Audit Decoding the IRS Audit Process
Travis A Greaves,T Joshua Wu
60 Min
Product Id: 705154
Both clients and tax advisors should be aware of the IRS audit process. This webinar will introduce advisors and clients to factors the IRS considers in selecting an individual for audit, how the IRS obtains information during the audit, and provides you the tools needed to represent the client through IRS appeals.
Process Validation - Current Industry Practices and FDA Guidance Document Review
John R Godshalk
60 Min
Product Id: 705316
This webinar will cover basics of process validation along with current industry practices. It will also discuss recent FDA draft guidance document and the importance of good process validation.
Post Market Surveillance for Medical Devices
Daniel O Leary
90 Min
Product Id: 702377
This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.
Cardiology E/M Coding: Hospital and Office Documentation Compliance
Terry Fletcher
60 Min
Product Id: 705312
This webinar will address coding along with billing and payments for the evaluation and management (E/M) services for the cardiology specialty. It will also cover reimbursement issues and best practices to maximize reimbursement opportunities.
New Home Health Conditions of Participation
Sharon Litwin
90 Min
Product Id: 705337
This CMS compliance training will address the key changes in the new Conditions of Participations (CoPs) that will be effective July 13, 2017. It will focus on the change processes and policies for patient rights, aide services, evolving plan of care, infection control, emergency preparedness program, QAPI and more.
The Provider Self-Disclosure Protocol (SDP) and the OIG - Compliance: Self-Reporting to OIG - When Should this Happen and How to do it?
Laura S Hargraves
60 Min
Product Id: 703650
The course will instruct attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting.
Personal Protective Equipment for Scientific and Construction Operations
Keith Warwick
60 Min
Product Id: 705313
This course will describe how to develop a job hazard analysis to address chemical hazards and develop controls to protect workers. It will emphasize the need for PPE (personal protective equipment) training and address the appropriate PPE gear to protect construction workers and to use in laboratories.
Drug Pharmacy Compounding
Rachelle D Souza
60 Min
Product Id: 704907
This webinar will discuss conditions under which certain compounded human drug products are exempted from compliance with cGMPs, labeling, market approval and reporting requirements. It will cover conditions that require an outsourcing facility to comply and the latest developments in drug pharmacy compounding.
The New OFAC - OFSI?: Iran Financial Sanctions, Guidance & Many More
Shaun Miller
90 Min
Product Id: 705160
This training program will examine the process for imposing monetary penalties for breaches of financial sanctions. It will also deconstruct the process for imposing monetary penalties for breaches of financial sanctions: consultation, operating within counter-terrorism legislation.
Pharmaceutical Packaging - Regulations and Testing Standards
Thomas Feinberg
90 Min
Product Id: 705305
This webinar will present the current state of US and EU (pre-Brexit) regulatory policy with some insights into the CFDA (China) related to pharmaceutical packaging and testing. A unified risk assessment strategy will be presented to guide laboratory and eventual regulatory reporting activities.
ICH Q11 - API Manufacturing
Peggy Berry
90 Min
Product Id: 705303
The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. By the end of this program, attendees will understand the requirements of the ICH Q11 guidance and learn skills for practical implementation of those requirements.
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects
John R Godshalk
60 Min
Product Id: 704841
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
Impact and Control of RFIs on Construction Projects
Jim Zack
90 Min
Product Id: 704288
This webinar discusses the genesis of RFIs and their development and the use and abuse of RFIs on construction projects including ways to mitigate the potential adverse impact of RFIs. Speaker discusses a number of contractual mechanisms to control the RFI process and mitigate potential impact damage claims based on the number of RFIs. The webinar also sets forth best management practices concerning the RFI process.
The IRS is Coming: How to Prepare for the New IRS Partnership Audit Rules
Travis A Greaves,T Joshua Wu
60 Min
Product Id: 705112
The new IRS partnership audit rules require all partnership and LLCs taxed as partnerships to amend their partnership agreement and take action now. In this training program, attendees will learn how these rules impact your business and your clients. The session will discuss IRS issues with TEFRA (Tax Equity and Fiscal Responsibility Act) and detail the concepts and terms in the Bipartisan Budget Act.
Three Ways Home Healthcare is Changing the Medical Device Game
Tom Kramer
60 Min
Product Id: 705228
This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.
HIPAA and the Compliance Officer
Brian Tuttle
60 Min
Product Id: 704744
This training program will be address how practice/business managers (or compliance officers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016.
The Revised Total Coliform Rule (RTCR)
Michael Brodsky
60 Min
Product Id: 705279
This training program will discuss in detail the requirements of Revised Total Coliform Rule (RTCR) including its history and background, key provisions, comparison with the TCR (Total Coliform Rule) and much more. It will also describe the best practices to comply with the RTCR requirements.
Vendor Qualification for Quality Services
Todd Graham
60 Min
Product Id: 705285
This webinar will teach you how and when to implement complimentary activities to an outsourced quality function and how to integrate this information into a fully-functioning program.
California Leaves of Absence Compliance Including FMLA, Pregnancy Disability, and Military Leave
Allen Kato
90 Min
Product Id: 705273
This California leave of absence compliance training program will guide attendees with effective administration of leave of absence and help identify and prevent employee abuse of leave. Understand the essential elements and legal developments behind FMLA, pregnancy disability, and military leave laws.







