Compliance Training Webinars for Regulated Industries

This 3-hr virtual seminar on the FDA New Drug Approval Process will cover the NDA and ANDA review and approval process including a discussion of preparing NDAs and ANDAs, relevant meetings, timing, costs, approval requirements and other FDA regulatory requirements. The various existing regulatory approval pathways (the “full” NDA, the 505(b)(2) NDA and the ANDA) will be discussed.

This 3-hr virtual seminar on OSHA Subpart Z (or IH) Regulations will discuss many of the individual standards as well as the general model and approach and “template” that OSHA takes with these IH regulations.

This FDA Good Documentation Practices training will introduce and explain the concept of Good Documentation Practices, and provide real-world examples of how to, and how not to, use GDPs.

This 3-hr virtual seminar on the New Changes to the HIPAA Regulations will discuss the details of changes, how these changes will affect your organization and your Business Associates, new penalties and enforcement of HIPAA.

This 90-minute webinar on workplace social networking will cover legal concerns for HR professionals arising out of employees posting inappropriate content on social networking sites, and in using social media for conducting background checks.

The following is a pack of 3 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance with the EU Medical Device Directive, obtain CE marking and fulfill ISO requirements.

This 90-minute webinar on creating an Affirmative Action Plan will show how you can collect Applicant Flow data, track information from the hiring process and use it to build Affirmative Action Plans.

This Form W-2 Compliance training will provide in-depth information that will help you to correctly complete, reconcile and file a Form W-2.

This 5-hr GMP requirements training for Combination Products will help you understand FDA's draft guidance on GMPs for Combination Products and provide practical solutions and tools for revamping your quality system to meet this new paradigm.

This Validation of Bioanalytical Assays webinar describes logical approaches to efficiently develop assays that will deliver quality data.

This webinar on Documentation and Discipline will cover discipline policies, standards of conduct, and the process of counseling and progressive discipline, up to and including terminations. It will also cover legal aspects of discipline and discharge.

This 6-hr webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.

This Software Project Management training is designed to help executives and managers set and deliver on appropriate and realistic expectations, and avoid the 90% Syndrome.

This Software Testing training will review a testing method based on 'Design of Experiments' to greatly reduce redundant test cases and ensure that maximum number of defects are found.

This 90 minute webinar on legal HR documentation will address why documentation is important in every employment decision you make. Learn from real life lessons, from actual court cases, of how documentation helped an employer to win its case and how wrong documentation ensured a loss.

This 3-hr virtual seminar will cover the USFDA's regulation of cell therapies and HCT/Ps, FDA's labeling and promotional rules and the agency's current enforcement activities in the areas of cell and gene therapies, and HCT/Ps generally.

This 3-hr presentation covers specific issues affecting Credit and Accounts Receivable, including Credit Risk Management, the adequacy of provisions for Bad Debt, Collection Procedures, dependence on processes outside the credit department, and outside the company. This seminar will help Credit Professionals understand their responsibilities and duties so that they can be confident that their Credit and Accounts Receivable processes are Sarbanes-Oxley compliant.

This 4-hr virtual seminar will focus on Japan's overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. It will cover topics relating to pre-clinical and clinical requirements and address the structure of the regulatory agencies in Japan.

This webinar on Telemedicine Programs will focus on critical issues to be addressed before joint program connecting remote and central locations is planned and implemented. New technical and regulatory developments like that of FDA on Medical Data Device Systems (MDDS) and its implications on the telehealth community will be discussed.

This webinar on OFCCP Compliant Compensation Programs will focus on what to expect from the OFCCP with regard to your Pay Programs, recent enforcement initiatives and principles of establishing an equitable pay system.