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   + GXP (GDP, GWP, GMP, GLP, GCP, ...)

Laboratory GMP / GLP
Why GLP / GMP?
Who must perform?
Responsibilities
Education
Lab. General

Lab Equipments (USP-AIQ)
Label
Logbooks
Which equipments should be calibrated?
Which equipments should be validated?

Dokümantasyon GDP
Which info should be recorded?
Logbooks or Forms?
How should the deviations be evaluated?
Raw Data
Validation

Equipment and Raw Materials
Label
Purchase

Standards and Samples
Classifications
Which info should be recorded?
Lab. Practices
Records and Reports
OOS Assessment
What is OOS?
Research Principles
Responsibilities
If there are valid reasons?
If the aren't valid reasons?
Re-test?
Re-sampling?
Outlier Test?
Decision
How can OOS be prevented?

Training of Lab Personnel
Authority Expectancy

Personnel Process
Job Definition
Selection Process
Orientation
Training
Adequacy & Efficiency
Continuity
When to train?
Quality Assurance

cGMP
Comparison of EU and FDA cGMP Requirements
The Points They Match
Critical Differences

Quality Systems Approach to cGMP Requirements
Risk Based Approach
Quality Systems and cGMP
Quality
Quality Design
CAPA
Quality Risk Management
Change Control
Quality Department

Quality Management (Eudralex Chapter 1)
Basic Rules
Quality Assurance
Good Manufacturing Practices For Pharmaceuticals (GMP)
Quality Control
Product Quality Review

Certification and Product Release by Qualify Person (QP) (Annex 16)
QP Responsibilities In One Or More Site
Contract Production Outside EU
Supporting Organization For Effective Working With QP
Quality Problems, Limitations on Production Site and Registration

Improving Site Master File- A Requirement of EU
Why is there a requirement for master file improvement?
What should be the main issues of master file?
The most important areas?
Required Areas?

CGMP Audit Site Choosing Model
Risk and Mathematical Factors
Six-system auditing model
Pharmaceutical Inspection Committee
FDA Audit
Frequency
Observations
Authority Expectations
Revised cGMP Alert Letter Procedure

EU Audit (Eudralex: Other Documents Related GMP)
EU-Related to Products or Process
GMP Audit Reports- Critical, Major, Minor
Audit Interval, Which Phase?
Mutual Recognition Agreement?
“Compilation of Community Procedures on Inspections and Exchange of Information”
Quality System for Auditor Team
Defect Reports, Alert and Product Recall Announcement
Procedures Related with GMP Audit
Revised Formats, Formal GMP Certificates
Central Pharmaceuticals Licence Application Procedures

FDA Current Topics
FDA Pharmaceuticals Records And Listing
Recommended Rules
National And International Recording And Listing Requirements
For Human Pharmaceuticals And Pharmaceuticals Compiled Under Biological Licence
Implementation
Critical Path
The Challenge
The Diagnosis
The Prescription
Barcode Labelling Requirements
History
Objective
Requirements
Implementation Dates

Production Of Researched Pharmaceuticals, Product Specification File, PSF, Annex 13
How should the requirements be met?
The authority expectations?
Pharmaceutical development, how to benefit from PSF?
How can PSF be applied efficiently?

CGMP for API (Part II, Annex 18)
Differences between Annex 18 Part2 and ICH Q7?
Audit of API Manufacturers
Product Quality Review (EU) And Yearly Product Review (FDA)
What are the basic differences between API and pharmaceutical producers?
What is important?-Critical and Non-Critical Phases

Sterile Pharmaceuticals (FDA)
Industry Hand Book
History & Objective
General Requirements

Sterile Pharmaceuticals (Annex 1)
Basics
General
Production Areas
Equipments
Aseptic and Terminally Sterilized Products
Sanitation

Qualification and Validation (Annex 15)
Validation Plan
Documentation
Qualification
Process Validation
Process Cleaning Validation
Change Control
Re-validation

Pharmaceutical Development
History & Objective
Pharmaceutical Components
Formula Improvement
Production
   + Hygiene
   + Change Control
Introduction to Change Control
What is change control?
Why is change control required?
Authority Rules/Guidelines of Change Control
Type I/Type II Changes (EU Requirement)
Pre-approval Annexes/ CBE-30/CBE (FDA Requirement)

Establishment of Change Control System
Responsibilities
Relation with Quality System
Documentation

Implementation of Change Control
Sites and Equipments
Change of Production Site
Material Management
Change of API Supplier
Production
Change in Production Process
Packaging and Labelling
Change of Label Text
Laboratory Systems
Change of Contract Test Laboratory
   + Deviation and CAPA Corrective & Preventive Action – CAPA
First Step of CAPA / GMP CAPAbility
Basic Steps Of CAPA

Correction, Corrective and Preventive Action
Correcting and CAPA in the Long Period
Where and when is CAPA required? (Deviations/OOS/QS/Internal and External Audit)
FDA/21CFR Requirements for CAPA and CAPA Management (21 CFR Part 820.100)

Wrong Approaches to CAPA system
Why is CAPA required?
Main Problems and Wrong Approaches
CAPA and Risk Assessment
Root Cause Techniques

Critical Deviation Management (CDM)
Using CAPA Only In Critical Deviations
Management of Non-critical Deviations and Tracking Trends
Trends Causing Preventive Action

Authority Expectancy From CAPA System (FDA QSIT Guide)
How is CAPA prevented? (Risk Assessment & CDM Applications)
CAPA: Responsibilities, Follow-up and Closing
   + Risk Management
Introduction to Risk Management
Risks and Threats
Reducing or Moderating Risk
Risk Management Rules/Guidelines with ICH Q9

Methodologies, Equipments and Techniques
Process Planning
Typical Production Processes
Potential Threat Analysis
Water System
Event Tree Analysis and fault Three Analysis
Complaints and Recall
HAZOP
Production Processes
FME(C)A
Equipment Validation
HACCP
Production Processes
Risk Priority
Supplier Audit
   + GMP Documentation
   + Sterile Operations
   + Audit
Audit General
Reference Documents
Definitions
What should be audited and why?
Audit Types
Audit Roles

Audit Skills
Good auditor?
Good auditee?
Bad auditor?
Bad auditee?
Good Auditing Practice

Personnel
Auditor Team
Auditor Training
Auditee Trainiing

Non Technical Issues In Auditing
Question Types
Asking The Right Question
How is a question answered?
Body Language
Interview Techniques
Listening Skills
Dealing With Difficult People

Taking Notes
What should be recorded?
How to record?

Audit Plan
Objective of Audit
Audit Team
Information in Hand

Auditee
Preparations
Behaviours

Audit
Audit Logistic
Audit Schedule

Technical Aspect of Audit
Audit Checklists
FDA Approach
Preparation of Audit Checklists

After Audit
Closing Meeting
Writing The Report
Classification of Findings
   + Quality etc.

Please visit www.academialsc.com for training schedule.
NEWS
FAQ
+  What is Validation?
+  What is a Protocol?
+  What is Installation Qualification?
+  What is Operational Qualification?
+  What is Design Qualification?
+  What is Prospective Validation?
+  What is a Clean Area/Room?
+  What is fumigation?
>> more...
     
     
 
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