Webinars
Refine Search
![Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/JOY_MCELROY-80x90.png)
Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the FDA finalize..
![Mastering Coaching and Mentoring for Outstanding Job Performance Mastering Coaching and Mentoring for Outstanding Job Performance](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/CHRIS-DEVANY-80x90.png)
Mastering Coaching and Mentoring for Outstanding Job Performance
Empower your employees to become more productive, effective, and committed team members!In today’s tough business environment, your organization can’t afford anything less than outstanding performance. Are you prepared to get the best from your team? Keep your team members’ productivity up to par—and show them how to do the best job they can? You’ll learn a step-by-step approach to effective coaching and su..
![Mastering The Leap To Management Mastering The Leap To Management](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/LARRY_JOHNSON-80x90.png)
Mastering The Leap To Management
Going from being a doer to one who manages others doing can be a daunting challenge. This webinar gives new managers tools to help them succeed in their new role.In this 60 minute webinar, Larry will provide you answers to some of the common problems new managers face like:Understanding the psychological challenges of making the leap to a managerial/supervisory role Avoiding five big mistakes every new mana..
![Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/JERRY_DALFORS-80x90.png)
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenteral and medical devices. Sinc..
![Maximize the Return on Your Hiring Investment: How to Welcome, Engage, and Retain New Employees with Your Onboarding Strategy in 2020 Maximize the Return on Your Hiring Investment: How to Welcome, Engage, and Retain New Employees with Your Onboarding Strategy in 2020](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/SUSAN_STRAUSS-80x90.png)
Maximize the Return on Your Hiring Investment: How to Welcome, Engage, and Retain New Employees with Your Onboarding Strategy in 2020
Whether you call it Onboarding, Induction, Enculturation, or New Employee Orientation (NEO), the process used to welcome and train your new employees while capturing their excitement of a new job and reducing their new job jitters is critical to their success. NEO is not a one-day event, but rather a process that begins after their acceptance of the job and extends through the first year of their employment..
![Maximizing Organizational Change: How to Manage Transitions, Dynamics and Benefits Maximizing Organizational Change: How to Manage Transitions, Dynamics and Benefits](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/CLAUDETTE-ROWLEY-80x90.png)
Maximizing Organizational Change: How to Manage Transitions, Dynamics and Benefits
It’s often cited that 70% of change or transformation initiatives fail (McKinsey, Kotter, Blanchard). Much of the research into these failures point a lack of planning, communication, and recognition of the impact on employees. William Bridges, author of Transitions and numerous other publications, notes that once leaders announce a change to their organization, they have already spent around six months pon..
![Mediating Construction Disputes – How To Be Successful Mediating Construction Disputes – How To Be Successful](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/James%20G.%20Zack-80x90.jpg)
Mediating Construction Disputes – How To Be Successful
Mediation is not new. Mediation was employed in ancient India as well as in the Islamic world. In more recent times mediation has been widely adopted in the U.S. construction industry as a form of Alternative Dispute Resolution (ADR). Mediation is often employed when claims negotiations fail to reach a resolution in lieu of arbitration or litigation. The webinar discusses mediation as a process and discusse..
![Mediating Damages – How To Avoid Arbitration & Litigation Mediating Damages – How To Avoid Arbitration & Litigation](https://www.grceducators.com/image/cache/catalog/2022-Speaker%20/85-95/James%20G.%20Zack-80x90.jpg)
Mediating Damages – How To Avoid Arbitration & Litigation
Mediation is not new. Mediation was employed in ancient India as well as in the Islamic world. In more recent times mediation has been widely adopted in the U.S. construction industry as a form of Alternative Dispute Resolution (ADR). Mediation is often employed when construction claims negotiations fail to reach a resolution in lieu of arbitration or litigation. The webinar discusses mediation as a process..
![Mediating Employee Complaints And Conflict Resolution Maneuvers For Managers Mediating Employee Complaints And Conflict Resolution Maneuvers For Managers](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/TERI%20MORNING-80x90.png)
Mediating Employee Complaints And Conflict Resolution Maneuvers For Managers
In a workplace, problems are solved all day long and interpersonal conflicts should be just another problem to be solved. However, it’s always easier to solve problems regarding things. But the people side of problems is usually trickier and in actuality, it’s highly unlikely that any problem solved in the workplace doesn’t have a people element to it. Some people like to say nothing in business is personal..
![Medical & Recreational Marijuana – Impact on the Workplace Medical & Recreational Marijuana – Impact on the Workplace](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/DIANE-L-DEE-80x90.png)
Medical & Recreational Marijuana – Impact on the Workplace
Recently, the Department of Justice has made moves that indicate its intent to enforce federal law in jurisdictions where marijuana has been legalized. Traditionally, many employers have had one-size-fits-all policies that have zero tolerance for any use of marijuana. Considering the wide variety of state laws and recent court cases, employers need to evaluate their own policies regarding the use of medical..
![Medical Device Complaints and Corrective and Preventative Action (CAPA) Medical Device Complaints and Corrective and Preventative Action (CAPA)](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/EDWIN-WALDBUSSER-80x90.png)
Medical Device Complaints and Corrective and Preventative Action (CAPA)
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is str..
![Medical Device Recall Management Medical Device Recall Management](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/SUSANNE_MANZ-80x90.png)
Medical Device Recall Management
Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle a difficult situation. This webinar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and notifications to customers and regulatory bodies.This webinar w..
![Medical Device Regulations in the Middle East and North Africa Region Medical Device Regulations in the Middle East and North Africa Region](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/JOSE_IGNACIO_MORA-80x90.png)
Medical Device Regulations in the Middle East and North Africa Region
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yem..
![Medical Device Risk Management Following ISO 14971:2019 Medical Device Risk Management Following ISO 14971:2019](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/EDWIN-WALDBUSSER-80x90.png)
Medical Device Risk Management Following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post-production risk management program is implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is described in ISO 14971. This is the most powerful of the risk management techniques because it considers ris..
![Medical Device Software 62304 Compliance Medical Device Software 62304 Compliance](https://www.grceducators.com/image/cache/catalog/Speaker/85x95/CAROLYN-TROIANO-80x90.png)
Medical Device Software 62304 Compliance
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device sof..