Aware of the Similarities and Differences in the files

  • 150.00 Dollar US$
  • Published date: November 27, 2017
  • Modified date: January 19, 2018
    • Fremont, California, United States

Overview:
It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes.

Why should you Attend:
companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical File or Design Dossier.

Areas Covered in the Session:
DHF "Typical" Contents and Deliverables
The DMR and DHR / Lot / Batch Record
TF / DD Required Contents
Parallel Approaches to Documentation - Teams
FDA and NB Audit Focus

Who Will Benefit:
QA
RA
R&D
Engineering
Production
Operations
Marketing

Speaker Profile:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Full Details & Registration Link:
http://www.compliance4all.com/control/w_product/~product_id=501651LIVE?channel=marketplace_Jan_2018_SEO

Result 0 votes
Compliance4All
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Using VLOOKUP, MATCH, and INDEX

    Using VLOOKUP, MATCH, and INDEX

    Other Services Fremont (Fremont/CA) September 25, 2019 110.00 Dollar US$

    Overview This webinar is for any user of Excel who works with large amounts of data and has data in multiple worksheets. Learning about the lookup functions will allow you to match data between databases. Learn about VLOOKUP function in Excel which e...

  • it works naturally in order to optimize sexual health

    it works naturally in order to optimize sexual health

    Other Services New York (arizona) August 29, 2019 Free

    They are all Ramulast. It's a bite sized chunk. It is decent to me how counselors cannot relate to a plain Jane realm like Ramulast. It only required a bit of time. Going back to my experiences with Ramulast, what I have is an opposition regarding Ra...

  • 2-day In-person Seminar Applied Statistics for FDA Process Validation

    2-day In-person Seminar Applied Statistics for FDA Process Validation

    Other Services Philadelphia (Philadelphia, PA) August 8, 2019 2000.00 Dollar US$

    In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates...