Election Year Legal and Compliance 2012
Michael Bayes ,Jason Torchinsky
75 Min
Product Id: 702228
This webinar on Federal Campaign Finance Law will assist compliance officers and in-house counsel identify common campaign finance issues faced by corporations and trade associations in major election years.
3-hr Virtual Seminar - Affirmative Action Compliance and Your Recruiting Strategy: Pulling it together
Cathleen M. Hampton
3 hrs
Product Id: 702077
This 3-hr virtual seminar will take a deeper look at your recruiting practice and review the objective for affirmative action as it relates to this function in terms of ensuring compliance. The session also features a discussion about how to make the most of your recruiting technology so that you are prepared to meet the OFCCP’s recently heightened enforcement efforts.
Validation of Existing/ Legacy Computer Systems for FDA/EU Compliance
Dr. Ludwig Huber
75 Min
Product Id: 702303
This webinar on validating legacy computer systems will give a good understanding of FDA and EU regulatory requirements for validation (retrospective validation) and provide tools for effective implementation.
Best Practices for Maintaining an IND and IDE Application with FDA
Mukesh Kumar
60 Min
Product Id: 702254
This webinar on IND and IDE Application management will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.
The Top 6 HIPAA Security Issues: Minimizing Risks Related to Portable Devices, Remote Access, Disaster Recovery, Policies and Procedures, Training, and Documentation
Jim Sheldon-Dean
90 Min
Product Id: 702309
This 90-minute webinar will review the top HIPAA security issues that health information professionals face - encryption and mobile devices, remote access, disaster recovery, policies and procedures, documentation and training - and show what they have to do to mitigate the risks they present.
Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?
Mark Gardner
120 Min
Product Id: 702275
This 120-minute webinar will cover the new (Federal) Physician Payment Sunshine Act, the topics raised by the proposed rule and existing State sunshine laws. Attendees will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to the relevant authority.
How to Organize and Conduct Product Complaint Investigations
Charles R. McConachie
60 Min
Product Id: 702289
This webinar on product complaint investigations will provide the necessary information to those in food, drug, device, cosmetic and related industries that manufacture and distribute products to consumers on how to best receive, respond, investigate and correct product complaints in the best interests of the firm.
Lean Project Management For U.S. FDA-Regulated Industries
John E Lincoln
90 Min
Product Id: 702276
This 90-minute webinar on Lean Project Management for U.S. FDA Regulated companies will show how you can incorporate basic lean principles for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale, while addressing FDA / CGMP requirements.
Full-day Virtual Seminar: Critical Factors and Complexities in Payroll 201
Vicki M. Lambert
7 hrs
Product Id: 702201
This 7-hr virtual seminar on Payroll 201 provides high-level training on topics critical to the intermediate payroll professional. It will increase your knowledge of payroll procedures and compliance regulations beyond the mere basic skills.
3-hr Virtual Seminar: FDA Medical Device Regulation for the Beginner
Karl M. Nobert
3 hrs
Product Id: 702299
This 3-hr virtual seminar will provide an introduction to FDA’s Regulation of Medical Devices and is intended for the Beginner. It will cover device classification, the device manufacturer’s and/or distributor’s regulatory responsibilities, requirements for labeling and user fees, fda inspections and enforcement.
21CFR Part 11 - Predicate Rules Compliance
Alfonso Fuller
60 Min
Product Id: 701328
This 21CFR Part 11 training will clarify the relationship between predicate rules and 21 CFR part 11 compliance, allowing companies to satisfy FDA with a minimum of effort.
Handling Supplemental Pay Under the FLSA
Michael Haberman
60 Min
Product Id: 702271
This webinar on handling supplemental pay will help you ensure that your supplemental pay practices are in compliance with the Fair Labor Standards Act. It will review in detail all areas of supplemental pay.
Life Cycle Validation of GMP Potency Bioassays
Ana Menendez
90 Min
Product Id: 702195
This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034.
Off Label Product Use Discussions in Social Media
John E Lincoln
90 Min
Product Id: 702264
This 90-minute webinar will review FDA expectations/ requirements for discussing off label uses of medical products on social media, e.g.,Twitter®, Facebook®, etc. We will also discuss key elements of the FDA's new Draft Guidance, "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices", Dec 2011.
Good Documentation Practices for GXPs
Anne E Maczulak
60 Min
Product Id: 701320
This webinar on Good Documentation Practices will review the FDA requirements for documenting data in preclinical and clinical studies and manufacturing activities.
QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
Gregory Martin
120 Min
Product Id: 702278
This 120-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.
HPLC Method Development and Validation
Edward O Connor
60 Min
Product Id: 702269
This webinar on HPLC Method Development and Validation will outline similarities and differences in validations, and regulatory requirements, outline approaches specific to HPLC and to the various hyphenated detections systems.
Complying with Legal Interviewing and Hiring
Marna Hayden
60 Min
Product Id: 702148
This webinar will cover Interviewing and Hiring in compliance with employment law and show how you can conduct the selection process with confidence.
How To Respond To A FDA Inspection And Warning Letter
Charles R. McConachie
120 Min
Product Id: 702255
This Webinar will help you understand the current FDA requirements for IND and IDE application post initial approval to proceed with the clinical trial.
The HR Practitioner's Guide To Adverse Impact Analysis
Stephanie R Thomas
90 Min
Product Id: 702223
This 90-minute training on Adverse Impact Analysis will provide the right approach to preventing adverse impact and show how you can address its cause. You will learn about quantitative tools you can use to examine your employment policies and practices and proactively monitor for adverse impact.