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Pharmaceutical / Medicinal
MAR
3
Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies This program combines general considerations for Good Manufacturing Practice (GMP) compliance management with the principles of phase-appropriate GMP considerations, with an emphasis on needs of virtual companies. (“Virtual companies” are those wh...
03 - 04 Mar 2026
Online Event | United States
MAR
10
BPS
9th Annual Bioprocessing Summit Europe Bioprocessing Summit Europe brings together 650+ professionals from industry and academia, along with 60+ exhibitors, to advance the manufacture, quality, and control of cutting-edge biologics, genetic therapies, peptides, and oligonucleotides. ...
10 - 12 Mar 2026
Barcelona, Spain
MAR
11
40th Pharmacovigilance UK & EU 2026 40th Pharmacovigilance UK & EU 2026 11 & 12 March 2026, Sheraton Skyline, Heathrow, London, UK This event will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the...
11 - 12 Mar 2026
Hayes, United Kingdom
MAR
17
Verification and Validation - Product, Equipment/Process, Software and QMS Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning: Start with a Master Va...
17 - 18 Mar 2026
Online Event | United States
MAR
18
OPTC
OPT Congress 2026 OPT Congress 2026 is the leading industry event for scientists, directors, and technology providers driving innovation across oligonucleotide, mRNA, and peptide therapeutics. Now in its 11th year, this event provides a unique forum for translating...
18 - 19 Mar 2026
Boston, United States
MAR
19
SOP Writing, Training and Compliance in the Pharmaceutical Industry Recording of Live Virtual Seminar conducted on June 19-20, 2025 Complete this training at your own pace within 5 working days. The recording will be enabled on your convenient dates. Standard Operating Procedures (SOPs) are the basis for a lar...
19 - 20 Mar 2026
Online Event | United States
MAR
23
Change Control Best Practices - Avoiding Unintended Consequences of Changes One of the top 10 FDA 483 and Warning Letter citations is for inadequate change control. Change control receives detailed scrutiny during FDA inspections, and FDA reviews change control documentation to determine that changes did not adversely imp...
23 - 24 Mar 2026
Online Event | United States
MAR
24
VIPRY 2026
9th Annual Pharma Regulatory Summit 2026 9TH ANNUAL PHARMA REGULATORY SUMMIT 2026 “Driving Regulatory Excellence for a Changing Pharma Landscape” 24th March 2026, Hotel Kohinoor Continental, Mumbai, India The 9th Annual Pharma Regulatory Summit 2026 congregates foremost globa...
24 - 24 Mar 2026
Mumbai, India

Oct
1

ANDA Submission and GDUFA Guidance

 
 Seminar/trade show (noCPF)

When:

  01 Oct 2020

Where:

  Online Event

Website URL:

  https://www.complianceonline.com/anda-submission-gdufa-guide-webinar-training-706538-prdw?channel=brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Pharmaceutical / Medicinal

Keywords:


Event description:

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions In addition, with the passage of GUFDA II which significantly changes the fee structure, it is also crucial to understand the major changes to the program, and the effects of those changes on the generics industry. This webinar explains the submittal process of drugs and medicinal products and also explores the GUFDA II Guidance.

Posting date:

09 August 2020  |  643 views

Placement:

Not-featured (How do I make my event featured?)