PHARMA WEBINARS » Upcoming Microbiology Events

Data integrity has become a non-compliance area often observed by the FDA and reported within form FDA 483s and warning letters.  While various governments have observed this on
Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that
In 2015, MHRA issued a comprehensive guidance on the subject of data integrity followed by another in 2016 to broaden the topic. In 2018, MHRA finally issued the full complete guidance. 
Throughout the manufacture of pharmaceutical products, both non-sterile and sterile products are susceptible to the microorganisms they contact during the manufacturing process.  This Pharma webinar will equip attendees
Sterility testing practices (USP<71> Sterility Tests) comprise the historical "gold standard" for releasing pharmaceutical and biotechnology products as sterile. Because extensive contamination is often required

Microbial Data Deviation Investigations, Deviations, OOS, CAPAs and Risk Management

Date: Aug 08 - Aug 08
Sector: W, C, P, V
Type: Training

Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to

Microbial Data Deviation Investigations

Date: Aug 08 - Aug 08
Sector: P
Type: Training

Microbial data deviation investigations come in a multiplicity of forms and may vary from the very simple to include the incubation of a plate at an incorrect temperature to

Cleaning Validation; Understanding the Latest FDA, EU, EMA, Health Canada Requirements 

Date: Aug 13 - Aug 13
Sector: W, C, LE, O, P, V, CC
Type: Training

This 2 hour live interactive training webinar presented by Destin LeBlanc will examine cleaning validation helping you to understand the latest FDA, EU, EMA, and Health Canada requirements for

Risk Management of Raw Materials in a GMP Environment

Date: Aug 19 - Aug 19
Sector: W, C, LE, P, V, CC
Type: Webinar

Risk management of raw materials in a GMP environment is an area that is often overlooked as a Company develops new products. Depending on the product being developed, e.
The European Medicines Agency (EMA) recently published “Sterilization of the Medicinal Product, Active Substance, Excipient and Primary Container” which has an effective date of October 2019. 
This live interactive training webinar will explore microbial recovery.  Microbial recovery is an often discussed topic within both non-sterile and sterile environments with microorganisms. Microbial recovery concerns itself
Burkholderia cepacia and its BCC Complex are bacterial species that are ubiquitous in nature and often found as a frequent recall issue based upon CDER data. Pharmaceutical products that

Regulatory Aspects of Microbiology in a Non-Sterile Environment

Date: Oct 10 - Oct 10
Sector: W, P, V, CC
Type: Training

Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal when compared to aseptic manufacturing. These include the handling and evaluation

Investigating FDA Data Integrity Regulatory Issues in a Manufacturing/Laboratory Environment

Date: Oct 15 - Oct 15
Sector: W, C, P, V, CC
Type: Training

Data Integrity has become a non-compliance area often observed by the FDA and reported within Form FDA 483s and Warning Letters. While various governments have observed this on a

Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements

Date: Oct 16 - Oct 16
Sector: W, P
Type: Training

Knowledge of the microbiology of water in a GMP environment is critical to the health of any water system being used to produce a pharmaceutical or biotechnology product. Even
This Live Webinar takes place at 10.30 AM -12.30 PM ET (New York Time)   Knowledge of the microbiology of water in a GMP environment is
Monitoring of in-process bioburden of pharmaceutical components, containers and closures, intermediates, drug substances and drug products are essential elements of the overall contamination control program for appropriate process control

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