Compliance Training Webinars for Regulated Industries

This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection. Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.

This Performance Documentation training will explore the elements of effective documentation and will offer practical useful tips for creating an environment where maintaining performance documentation is an easy part of the manager’s routine. Any employee status change that is based on performance (reassignment, demotion, termination) must be supported by adequate documentation.

This C-TPAT training will guide you on the annual training for employees to fulfill C-TPAT requirements by CBP.

This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence

This C-TPAT Revalidation training will help certified C-TPAT members understand what’s entailed for a revalidation and will provide tools to ensure a smooth revalidation.

This 510(k) Clearances training/webinar will provide valuable assistance to all regulated companies that need to validate their systems.

This HR compliance will review the critical elements of the Americans with Disabilities Act, the Family Medical Leave Act, Workers Compensation as well as other relevant state leave laws and provide solutions to managing absenteeism fairly. There are few things as disruptive to operations as unexpected absences of employees. Many organizations have come to value dependability of attendance over other employee characteristics.

This Internal Audit Approach training/webinar is designed to enhance your understanding of process auditing techniques Using interactive examples and a case study.

This presentation will review methods for finding predicates, using guidance documents and interacting with the agency. Participants will learn about the different types of 510(k) submissions and the benefits and drawback of using the 3rd party.

This Validation training will provide guidance in overcoming inherent variability in bioassays. Performing good optimization studies will lead to a well-defined method for future qualification and validation of the assay

This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.

Pilot has provided training in auditing since 1995 using her Three Step System Approach for Auditing and her Five Steps in performing audits This presentation cover in simple terms the five steps to conduct audits and the working documents required. 1 - Initiating, 2 preparing, 3 Conducting - opening/closing meetings, collecting evidence, findings, 4 Audit reports, 5 Audit completions.

Virtual SOX is one of the first open doors to effective and efficient sox compliance pathway. Using technology and local administrative talent we can gather backup documents, scan, upload and observe access controls. The concept of performing a Section 404 effort completely remote requires us to have a very different paradigm shift.

In this GSA compliance training we look back at the most notable GSA Schedule contractor violations of the year and how to keep those from happening to your company.

This Management control training will provide the principles and practices needed to effectively develop and implement the Management Controls to ensure an effective Quality Management System and to comply with the FDA QS Regulation.

This Complaint Handling training will discuss the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback.

This Risk management training offers a quantitative risk management approach you can use to measure system implementation and enhancement efforts against the criticality and business/regulatory significance of the system.

This GSA compliance training will provide valuable assistance to all GSA Schedule contractors and will review the 21 documentation libraries that every Schedule contractor should have.

This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.

This Validation training will provide valuable assistance to all regulated companies that need to validate their systems. Project management is the application of knowledge, skills, tools, and techniques to manage project activities to meet project requirements