• الصفحة الرئيسية
  • خدماتنا
  • دورات تدريبية
  • نبذة عنا
  • تواصل معنا
Login / Register
0 items SAR  0
Menu
0 items SAR  0
الرئيسية غير مصنف Manufacturing Process Validation for Regulatory Affairs & Process Validation for Sterile Products
Qualified Person form Pharmacovigilance (QPPV) SAR  3,277
Back to products
Validation, Verification, and Transfer of Analytical Methods SAR  4,485
Click to enlarge

Manufacturing Process Validation for Regulatory Affairs & Process Validation for Sterile Products

SAR  4,200

التصنيف: غير مصنف
Share:
  • الوصف
  • مراجعات (0)
الوصف
Tailored Course Agenda:
Day 1 Live Online: Manufacturing Process Validation:
  • Overview of ICH Guidance’s enhanced pharmaceutical development. Covering all Q guidance’s with reference to FDA, EMA and other regulatory considerations
  • Overview of the stages of process validation (Process Design, Process Qualification and Continued Process Validation)
  • Quality target product profile and Critical Quality Attribute identification
  • Analytical target profile, analytical method control strategy and importance of comparability studies
  • Process characterization studies, risk assessments (Failure mode and effects evaluation) and identification of critical process parameters
  • Process control strategy and demonstration of a process state of control
  • Process Performance Qualification (PPQ)
  • Continued Process Verification (CPV)
  • Equipment Qualification
  • Regulatory Readiness and Response
Day 2 Live Online: Process Validation for Sterile Products
  • Overview of regulatory expectations for sterile products with particular focus on Annex 1, FDA, and SFDA guidelines
  • Importance of a contamination control strategy with special consideration for ATMPS with no terminal sterilization possible
  • Terminally Sterilized Drug Products
  • Aseptically Filled Drug Products
  • Consideration for ATMPS with no terminal sterilization possible: validation of process and utilization of contamination control strategy
  • Considerations due to methods of aseptic equipment preparation.
  • Considerations related to specific drug delivery methods, Lyophilisation, prefilled syringes and others
  • Linking to the overarching process (drug substance / products) and product control strategies, integrating
مراجعات (0)

المراجعات

لا توجد مراجعات بعد.

كن أول من يقيم “Manufacturing Process Validation for Regulatory Affairs & Process Validation for Sterile Products” إلغاء الرد

لن يتم نشر عنوان بريدك الإلكتروني. الحقول الإلزامية مشار إليها بـ *

منتجات ذات صلة

Sold out

Pharmacovigilance for QPPV

غير مصنف
SAR  4,370
Date

18 May 2023

Location

Online

قراءة المزيد
Quick view
Sold out

Regulatory Compliance on Biosimilar & Biological

غير مصنف
SAR  3,900
Date

5.5.2024

Location

Online

قراءة المزيد
Quick view
Sold out

Impurities and Degradation in Drug Products

غير مصنف
SAR  4,800
Date

15 – 16 March 2023

Location

Riyadh – Saudi Arabia

قراءة المزيد
Quick view

Site Inspection Preparation & Readiness

غير مصنف
SAR  1,380
إضافة إلى السلة
Quick view
Sold out

Qualified Person form Pharmacovigilance (QPPV)

غير مصنف
SAR  3,277
قراءة المزيد
Quick view

Validation, Verification, and Transfer of Analytical Methods

غير مصنف
SAR  4,485
إضافة إلى السلة
Quick view

Quality Management Systems – Risk Management – Risk Assessment and Control

غير مصنف
SAR  1,150
إضافة إلى السلة
Quick view
Sold out

Qualified Person form Pharmacovigilance (QPPV)

غير مصنف
SAR  3,277
قراءة المزيد
Quick view
  • الموقع : السعودية - الرياض.
  • رقم الهاتف:
    (+966)920019011
  • البريد الالكتروني:
    info@mesned.com
اخر المقالات
موقعنا
  • السعودية
  • الأردن
  • مصر
الشركات الشقيقة
  • Mustanier for Health Training
  • ArabMed CRO
  • CalLab
  • Gulf Integrated
  • Contact Us
السوشيل ميديا
  • لينكد ان
Copyright ©2024 Mesned All rights reserved. Developed by SIMS Creation
payments
Close
  • الصفحة الرئيسية
  • خدماتنا
  • دورات تدريبية
  • نبذة عنا
  • تواصل معنا
  • Login / Register
Shopping cart
Close
Sign in
Close

Lost your password?

No account yet?

Create an Account
  • العربية
  • English (الإنجليزية)