Corporate Banner
Satellite Banner
Biomolecular Screening
Scientific Community
 
Become a Member | Sign in
Home>Events>This Event
  Events - June 2013


GMP Auditor Training for Quality Systems

11 Jun 2013 - 12 Jun 2013 - Amsterdam, Netherlands



Bookmark and Share


This 2 day course is aimed at Quality Assurance auditors and production management for Level 2 internal audits and supplier auditing.


To be a business benefit rather than a drain on resources, your auditing programmes must be integral to continuous improvement. The key to effective internal auditing and auditing of suppliers is the training of both auditors and auditees in the purpose and relevant techniques of the audit and how these techniques can be channelled to achieve business and compliance improvements.


Participants will learn about the key techniques and thought processes which may be used by auditors to maximize the benefits of each type of audit. These include planning and preparation, the audit team, structuring the audit, close out, CAPAs and follow up.


Who Should Attend?

  •   QA auditors and trainees
  •   Production managers who receive internal QA and corporate GMP audits
  •   Engineering managers who receive internal QA and corporate
  •   GMP audits
  •   Production supervisors who lead Self Inspection audits
  •   Auditors of suppliers and contractors

Course Programme

Part 1: Auditing Basics

  •   Purpose of audits and audit models (overview)
  •   Role Characteristics of the Auditor
  •   Audit Types and Classification
  •   Audit Methods
  •   General Themes for All Audits

Part 2: Auditing Tools and Techniques

  •   Basic auditing tools
  •   Audit Techniques
  •   Audit scheduling, planning and management

Part 3: The audit process

  •   Audit scheduling
  •   Conducting the audit
  •   Managing an Audit Team
  •   The Exit Meeting
  •   Audit Reporting and closeout

Part 4: Improving the audit system

  •   Adding Value from the Audit programme
  •   Organisation of the internal audit programme (Self Inspection)

Part 5: How to Audit CAPA, OOS and QRM

  •   The necessity for structured investigation
  •   Corrective and Preventive Action procedures
  •   Out of Specification procedures
  •   Risk Assessment techniques

Part 6: Auditing API Manufacturers

  •   Why Audit API Manufacturers
  •   Control of raw materials and process intermediates
  •   Handling Manufacturing Deviations
  •   QC Laboratories
  •   Distribution
  •   Computer systems
  •   QP Declaration

Part 7: Auditing Products Manufacturers

  •   Oral solid and liquid dosage forms
  •   Packaging and labelling
  •   Distribution
  •   QC Laboratories
  •   Computer systems

Part 8: Auditing for Approval of Contractors / Suppliers

  •   Technical requirements (physical properties, purity, quantity, frequency, etc)
  •   Critical steps and controls
  •   Preferred location (UK, EU, Far East, world-wide)
  •   Key points of contract (Quality Technical Agreement)

The course will include several Workshops on specific aspects of the programme



Further information
Scientific News
It’s Now Easier To Go With The Flow
Rice University tool simplifies comparison of flow cytometry data for laboratories.
FNIH Launches Project to Evaluate Biomarkers in Cancer Patients
Company has announced that it has launched a new project to evaluate the effectiveness of liquid biopsies as biomarkers in colorectal cancer patients.
Drugs that May Combat Deadly Antibiotic-Resistant Bacteria Uncovered
Study identifies 79 compounds that inhibit carbapenem-resistant Enterobacteriaceae (CRE).
Making Precision Medicine a Reality
Researchers are one step closer to understanding the genetic and biological basis of diseases like cancer, diabetes, Alzheimer’s and rheumatoid arthritis – and identifying new drug targets and therapies.
Potential “Good Fat” Biomarker
New method to measure the activity of energy consuming brown fat cells could ease the testing weight loss drugs.
MicroRNA Pathway Could Lead to New Avenues for Leukemia Treatment
Cancer researchers at the University of Cincinnati have found a particular signaling route in microRNA (miR-22) that could lead to targets for acute myeloid leukemia, the most common type of fast-growing cancer of the blood and bone marrow.
Soy Shows Promise as Natural Anti-Microbial Agent
Soy isoflavones and peptides may inhibit the growth of microbial pathogens that cause food-borne illnesses, according to a new study from University of Guelph researchers.
Doubling Down on Dengue
HMS researchers have discovered two ways a compound blocks dengue virus.
Soy Shows Promise as Natural Anti-Microbial Agent
Researchers from University of Guelph show that soy isoflavones and peptides could be used to reduce microbial contamination of food.
AstraZeneca to Sequence 2 Million Genomes in Search for New Drugs
Company launches integrated genomics approach which aims to transform drug discovery and development.
Scroll Up
Scroll Down
SELECTBIO

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!