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Intermediate Course for Regulatory Submissions in eCTD Format - October 2020

10.0RAC Credits
Thursday, 22 October 2020 (9:00 - 4:00PM)
td { font-size: 14px; border-color: white; }   Do you have a working knowledge of the CTD structure and need to learn how to correctly apply it to electronic submissions, or do you need to know what is required to comply with the FDA’s May 2020 guidances, this cou...

Introduction to Electronic Regulatory Submissions in the eCTD Format - October 2020

8.0RAC Credits
Tuesday, 20 October 2020 (9:00 - 4:00PM)
td { font-size: 14px; border-color: white; }   Do you need to comply with the impending electronic submission requirements for commercial INDs and Master Files?  Here’s the place to start . . . The deadline is fast approaching for your company to migrate to ...

Biologics CMC Workshop: Current Trends, Future Trends and Regulatory Challenges - September 2020

12.0RAC Credits
Tuesday, 29 September 2020 (9:00 - 3:00PM)
29 September 2020 (9:00 am–4:30 pm PDT) 30 September 2020 (9:00 am–3:00 pm PDT) Universities at Shady Grove 9630 Gudelsky Drive Rockville, MD 20852 Ensure your manufacturing process consistently produces safe and effective biologics. All stages of the drug develo...

RAPS Regulatory Convergence 2020

12.0RAC Credits
Saturday, 12 September 2020 (12:00 - 12:00PM)

Intermediate Course for Regulatory Submissions in eCTD Format - July 2020

10.0RAC Credits
Thursday, 16 July 2020 (9:00 - 4:00PM)
td { font-size: 14px; border-color: white; }   Do you have a working knowledge of the CTD structure and need to learn how to correctly apply it to electronic submissions, or do you need to know what is required to comply with the FDA’s May 2020 guidances, this course...

Introduction to Electronic Regulatory Submissions in the eCTD Format - July 2020

8.0RAC Credits
Tuesday, 14 July 2020 (9:00 - 4:00PM)
td { font-size: 14px; border-color: white; }   Do you need to comply with the impending electronic submission requirements for commercial INDs and Master Files? Here’s the place to start . . . The deadline is fast approaching for your company to migrate to electro...

Root Cause Investigation for CAPA

12.0RAC Credits
Wednesday, 20 May 2020 (9:00 - 5:00PM)
Root Cause Investigation for Correction and Preventative Action (CAPA) is a globally renown methodology for investigating technical performance challenges. Problem solving techniques from Six Sigma, 8D, Kaizen, DMAIC, TQM and others are leveraged to identify: Technical ...

Executive Development Program at the Kellogg School of Management

12.0RAC Credits
Sunday, 17 May 2020 (9:00 - 4:00PM)
Advance registration is required for Executive Development Program at the Kellogg School of Management. Participants are encouraged to register early. Onsite registrations are not accepted. Download the 2020 program agenda . Program Dates: 17-20 May 2020 Registra...

2020 Euro Convergence

12.0RAC Credits
Monday, 11 May 2020 (12:00 - 12:00PM)

Wisconsin Chapter: Embracing the Growth – An Update on MedTech in Asia

2.0RAC Credits
Thursday, 07 May 2020 (5:30 - 8:30PM)
Member: $30 Nonmember: $45 Although the medtech market in Asia is growing fast and fiercely competitive, it continues to be one of the most challenging for medical device manufacturers due to the complex regulatory requirements in each country. With developing and varying...