Yearly Archives: 2019

/2019

MDIC Releases Case for Quality CAPA Process Improvement Whitepaper

Medical Device Innovation Consortium/MDIC’s Case for Quality program today released a whitepaper recasting the Corrective and Preventive Action (CAPA) process as a continuous improvement process and to design a less burdensome process that drives higher product quality and improved patient safety. The whitepaper summarizes the initial findings and recommendations developed by a joint team from [...]

2019-12-19T18:22:20+00:00December 19th, 2019|

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – December 9-13, 2019

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. For [...]

2019-12-09T15:05:50+00:00December 9th, 2019|

2019 ISPE Global Pharmaceutical Regulatory Summit – December 5-6, 2019 in North Bethesda, MD

This forum brings together leading global pharmaceutical industry professionals and regulators to share their insights on technologies, approaches, and solutions that will drive innovation and quality for the medicines delivered to patients worldwide. This interactive setting with expert-led regulatory and industry presentations and forums will ensure pharmaceutical industry professionals are well-prepared to develop and apply [...]

2019-11-26T21:20:45+00:00November 26th, 2019|

The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – October 28 – November 1, 2019 in Arlington, VA

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 [...]

2019-10-24T18:03:59+00:00October 24th, 2019|

2019 ISPE Annual Meeting & Expo – October 27-30, 2019 in Las Vegas, NV

Why Attend 6 extensive education tracks -- Facilities & Equipment, Information Systems, Quality Systems & Regulatory, Innovation Forum, Supply Chain, Operations & Packaging and Process Development & Manufacturing 85+ hours of targeted technical sessions, from industry and regulatory leaders Networking opportunities, including 50+ Plenary and Technical Sessions, Facility of the Year Awards Program, Membership Awards Program, Facility [...]

2019-10-24T18:01:24+00:00October 24th, 2019|

Manufacturing Leadership Development Series – Module 7: Delegating Effectively – October 15, 2019 – 9 am to 12 noon ET

It is difficult in the day to day whirlwind to properly delegate and get the results that you are looking for. This module will take you through a step by step process for delegating effectively. Learn how to spend your time as a leader more productively and understand “SIMPLE” delegation methods. For more info:  https://chambermaster.blob.core.windows.net/userfiles/UserFiles/chambers/1492/File/Updated5.29.19_MFG_LeadershipDevelopmentSeries.pdf

2019-10-09T18:54:58+00:00October 9th, 2019|

Manufacturing Leadership Development Series – Module 6: Conflict Resolution – October 8, 2019 – 9 am to 12 noon ET

Wherever two or more people come together, there is the possibility of conflict. This module gives participants a six-step process that they can use to modify and resolve conflicts of any size. Participants will also learn crucial conflict resolution skills, including disagreeing diplomatically and using the Agreement Frame. For more info:  http://tnchamber.chambermaster.com/events/details/mfg-leadership-development-7-module-series-knoxville-09-24-2019-2453

2019-10-04T15:34:26+00:00October 4th, 2019|

2019 International Plasma Awareness Week (IPAW) – October 7-11, 2019

This event is held annually and is designed to: Raise global awareness about source plasma collection Recognize the contributions of plasma donors to saving and improving lives Increase understanding about lifesaving plasma protein therapies and rare diseases. Events will be held at plasma collection centers in both the U.S. and Europe. For more info:  https://www.pptaglobal.org/meetings-events/international-plasma-awareness-week

2019-10-04T15:31:52+00:00October 4th, 2019|

2019 ISPE APAC – Pharmaceutical Manufacturing Conference in Singapore, Asia – September 30 – October 1

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 [...]

2019-09-25T17:55:30+00:00September 25th, 2019|

Manufacturing Leadership Development Series – Module 5: Emotional Intelligence – October 1, 2019 – 9 am to 12 noon ET

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 [...]

2019-09-25T17:40:17+00:00September 25th, 2019|