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 1. Home
 2. Webinars
 3. ICH Q7 – GMPs for Active Pharmaceutical Ingredients


ICH Q7 – GMPS FOR ACTIVE PHARMACEUTICAL INGREDIENTS

--------------------------------------------------------------------------------

Faculty: John E. Lincoln

--------------------------------------------------------------------------------

 * Date: 8/9/2022 11:00 AM - 8/9/2022 12:30 PM
 * Location: Online Event

--------------------------------------------------------------------------------




TICKETS


Ticket Type
Price
Qty
Total
Live- Single
$200.00
$200.00
 
0
 
$0.00
For ONE Participant – Live session only
+ More info
Live Corporate
$700.00
$700.00
 
0
 
$0.00
For Maximum of 10 participants – Live session only
+ More info
Recording - Single
$350.00
$350.00
 
0
 
$0.00
Recording access for ONE participant (viewer) – Unlimited viewing access for 6
months
+ More info
Recording - Corporate
$1400.00
$1400.00
 
0
 
$0.00
Recording access (Multiple licenses) for up to 10 participants – Unlimited
viewing access for 6 months
+ More info

TOTAL

$0.00

Checkout
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DESCRIPTION

ICH Q7 is an internatioinal guidance document for recommended Good Manufacturing
Practices for APIs. Within the world community, materials may vary as to their
legal classification as an API. When a material is classified as an API in the
region or country in which it is manufactured or used in a drug product, it
should be manufactured according to this guidance. This webinar discusses the
key parts of ICH Qy that applies to the manufacture of APIs for use in human
drug (medicinal) products. It applies to the manufacture of sterile APIs only up
to the point immediately prior to the APIs being rendered sterile.

The sterilization and aseptic processing of sterile APIs are not covered by this
guidance, but should be performed in accordance with GMP guidances for drug
(medicinal) products as defined by local authorities. This guidance covers APIs
that are manufactured by chemical synthesis, extraction, cell
culture/fermentation, recovery from natural sources, or any combination of thes

Why You Should Attend:

This webinar is intended to provide guidance regarding good manufacturing
practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs)
under an appropriate system for managing quality. It is also intended to help
ensure that APIs meet the quality and purity characteristics that they purport,
or are represented, to possess.

Areas Covered in the Session :

 * The Basis QMS  – ISO 9001 (“13485”)
 * The ICH Q7 API GMP specifics 
 * Systems, Personell, the Physical Plant 
 * If it isn’t documented, it didn’t Happen
 * Control of material, product, manufacturing 
 * Laboratory Controls
 * Validations
 * Material / product rejection, release
 * Complaint handling and other post-production issues

Who Should Attend:

 * Senior management in Pharma, Combination Products
 * Pharma development and testing testing teams
 * Quality Assurance Departments
 * Quality Control Departments
 * Research and Development Departments
 * Regulatory Affairs Departments
 * Manufacturing Departments
 * Engineering Departments
 * Operations Departments
 * Production Departments
 * Validation Departments
 * Marketing Departments
 * Documentation Departments

 * Home
 * Seminars
 * Webinars
 * Courses
 * About us
 * Terms & Conditions
 * Refund Policy
 * F.A.Q's
 * Legal Disclaimer
 * Privacy Policy
 * Answers
 * Videos
 * Contact
 * Seminar on DI and Part 11
 * Seminar on FDA Inspection
 * more  
   * Seminar on Supplier Mgmt
   * GMP Master Class
   * Seminar on CSV DI for Clinical Trials
   * Seminar on CSA vs CSV
   * SaaS Cloud CSV
   * Seminar on Vendor Qualification
   * CSV Boot Camp
   * Seminar on SOP Writing
   * Seminar on Verification and Validation
   * Seminar on Technical Writing
   * Seminar on Analytical Method Validation
   * Seminar on QC Labs
   * QC Lab Compliance Seminar
   * Seminar on Analytical Instrument Qualification
   * Seminar on Internal Audits
   * Process Validation Training Course
   * Seminar on Lab Compliance Documentation
   * AI and SaMD - Quality Regulatory pathways
   * Self Inspection Techniques
   * Seminar on EU MDR
   * Seminar on Complaint Handling, MDR and Recalls
   * Seminar on Human Error Prevention
   * Statistics for Process Control
   * Seminar on BioStatistics

  Subscribe
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