Monthly Archives: September 2019

Regulators play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry. Securing first-hand regulatory insight gives you the advantage to make informed decisions and optimal regulatory strategies. At the 2019 ISPE Asia Pacific Pharmaceutical Manufacturing Conference, you’ll have the unique opportunity to tap into the minds of global regulatory decision makers [...]

Leaders are faced with many situations and must learn to remain calm in the face of adversity and stay sensitive to the needs of direct reports, peers and authority figures. This module reviews self– awareness and self-management, how to manage your emotions, and understand others’ emotions and how to manage in the workplace. For more [...]

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. For registration info:  https://my.aami.org/store/events/registration.aspx?event=DCIH093019

The annual Tennessee Chamber of Commerce & Industry Golf Tournament is September 30, 2019. For more info:  http://tnchamber.chambermaster.com/events/details/2019-tennessee-chamber-golf-tournament-sold-out-sept-30-2385

For many years software development teams have been using Agile Software Development methods, but Agile is not just for software. Agile’s Lean Product Development principles also apply to the development of hardware-based products and systems. This two and a half day course goes beyond small-team and software-only applications and demonstrates how Agile practices can be [...]

This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. For more info and registration:  https://my.aami.org/store/events/registration.aspx?event=DC0919

Upon completion of this 2-day course, participants will be able to evaluate the challenges with the use of Agile practices and be prepared to adapt these practices as needed to ensure the development of compliant, safe, and effective products. For more info and registration:  https://my.aami.org/store/events/registration.aspx?event=AP0919

Teams are typically comprised of people with diverse ideas and backgrounds and will always outperform individuals when leaders understand how to build these teams and leverage the strengths of all team members. This module defines types of teams and the typical roles and responsibilities associated with each and discovers problem solving as a team. For [...]

Coaching and mentoring comes in multiple forms and both are critical to the success of strengthening your team and building a solid succession plan for key leaders. This module defines and explains how to coach and mentor, how to set appropriate goals and coaching to achieve those goals, how to overcome common obstacles and develop [...]

This intensive 4 ½ day course provides quality system professionals with the information needed to develop and maintain a quality system program that conforms with the FDA's Quality System Regulation (21 CFR 820) and International Organization for Standardization 13485:2016, the international standard that spells out the requirements for regulatory purposes for quality management systems. Course [...]