InstructorRoyed Training
TypeOnline Course
Price$490 USD / 24500 INR.
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GMP and GMP audit management

Introduction

Course Type

Course Duration

Course Duration

Eligibility

Certification

Features

Related Courses

About GMP and GMP Audit

GMP and GMP audit

This online training on GMP and GMP audit provides extensive training on good manufacturing practices maintenance and audit for manufacturing plants. This course on GMP and GMP Audit advanced Certification course trains manufacturing professionals working in pharmaceutical, Biopharmaceuticals, Medical Devices, Food and FMCG companies.  This training gives practical knowledge and real-life job simulation how to manage the good manufacturing practices. Hence, this course provides insight on the GMP certification management process which need to be followed by manufacturing plant. Most importantly this course provides detailed insight on how to carry out GMP audit.

This course suits to pharmaceutical, biopharmaceutical, medical devices, FMCG, Food industry.

This is a real-life learning course which is specially prepared and designed not only for beginners but also for those who are currently engaged in the activities of good manufacturing practices but requires advanced skill to ensure compliance.

In this online self-paced module, participants will be understanding about the food regulation and commercialization process in detail. Therefore, it is easy and convenient to access. Course can be accessed 24×7, across anywhere.

The course trains the candidate how to handle regulatory audit like USFDA audit, MHRA UK, EMEA audit. Moreover, course covers importance of root cause analysis. And how to carry out CAPA. Above all, this course features advanced training on Data Integrity which is the major reason of GMP failure.

Course Title: RYD-045
Course Code: Advance Certification in GMP & GMP Audit Management

Online distance learning course. So, course can be accessed online across anywhere 24×7.

Who should attend this course? 

  • Those who are in pharmaceutical manufacturing unit.
  • Professionals who involve in manufacturing audits.
  • Regulatory professional who requires advance training on GMP management.
  • QA and QC person involving in plant audit.
  • Those who are handling plant audit.
  • External Audit Consultant.

1 Month.

Anybody who wants to acquire pharmaceutical international business management competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

Course Features:

This online GMP training course utilizes interactive learning tools to guide each participant through the steps of the drug development process. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The GMP course can be completed at any pace, allowing the user to stop and start at their leisure.

This course is divided into following modules

1. Quality : definition, evolution, attributes, concept and specific aspects for pharmaceutical products

2. GMP and its relationship with quality basics to specifics, History of GMP and its evolution and progress,

Progress of GMP with current status regulatory status and trends of various regulatory agencies with important milestones

3. GMP regulations and standards

4. Requirements, scope, objective and principles and practices of GMP with emphasis on GMP requirements of WHO ,TGA, MHRA, MCC, HPFBI, PICS, EU, ICH, USFDA and the new Schedule M.

5. Obtaining International GMP Certification and maintaining the GMP continuum.

6. Principles of Quality Assurance and Quality management Systems

Principles and Practices of Good Laboratory Practices,

7. Good Documentation Practices, water systems, stability studies,

8. Advances in GMP, Training and Auditing in GMP, Handling international GMP audits effectively and successfully,

Implementing GMPs in your organization, and getting the most out of quality by maintaining the GMP continuum.

9. GMP Audit

10. Specialized modules Pharmaceutical, Biopahrmaceuticals, Cosmetics, Medical Devices, Food plant GMP management and audit.

About GMP

Current Good Manufacturing Practices (CGMP) regulations are guidelines which are set by the Food and Drug Administration (FDA), United States’ food, drug and cosmetic product safety governing body. CGMPs provide guidelines to develop systems which ensure that manufacturing facilities and processes are properly designed, monitored and controlled.

An industry that operates according to CGMP regulations offers the market products whose quality, identity, purity, and strength has been tested and confirmed according to controlled manufacturing processes.

Part of CGMP for industries includes establishment of robust systems for quality control and management, using raw materials of proven quality, setting up strong operating procedures, identifying how quality deviations can be tested for products and maintaining consistent testing environments. Properly used, this scheme can be successful in curbing incidents of deviations, mix-ups, failures, contamination and other errors.

What is GMP and why is it so important?

Good Manufacturing Practices (GMPs) are systems created and mandated by the government to regulate production, verification and validation of drugs, food and/or medical devices, ensuring that finished products are effective and safe for market distribution.

It’s important to have GMPs because they are guidelines which are enacted to ensure food, drugs, cosmetics, medical devices and related products have no harmful substances. These regulations, enforced by the FDA, help reduce the instances of product recalls, harmful effects and eventual lawsuits that may arise from defective products.

Purpose of enacting CGMPs

The average consumer cannot, either by sight, smell or touch, detect whether food, drug or cosmetic products are safe and/or effective. One part of determining this is testing products at various stages of production, but this alone cannot sufficiently ensure quality.

This is because testing is carried out on a rather small batch of products (such as 100 devices from a production line containing one million devices). This way, majority of the products can be sold on the market to maximize profit for the manufacturer, rather than sacrificing them to test procedures.

As such, it is important to have guidelines/regulations governing every step, process, facility or equipment that will be used in the design and manufacture of consumer products. Facilities must be maintained in good condition, good clinical practice should be followed, employees should be properly trained and qualified, validation and verification of equipment should be done to maintain accurate, verified and calibrated measurements and processes should be consistent and reproducible.

These are the main areas covered by CGMP regulations. By complying with the standards established in the regulations, a company has the best chance of always manufacturing products that are effective, efficient and safe for consumer use.

GMP and other quality certifications

There are many quality assurance/control practices. CGMP distinguishes itself since it is mandatory for manufactures of products covered in the Food, Drug and Cosmetic Act. Others, such as ISO quality certification are not mandatory, which means manufacturers are encouraged, but not required to comply with them.

However, many of the aspects covered in the various quality standards are the same, differing only slightly in allowable thresholds. CGMPs include all guidelines relating to process validation, comprehensive corrective and prevent action (CAPAs), vendor qualification, good laboratory practice as well as design and managment reviews.

Failure to comply with CGMPS may attract immediate sanctions for an industry, whereas the same cannot be said of other QC standards like ISO.

Section 1Advanced Learning Modules
Lecture 1Certification Manufacturing Companies and Manufacturing Plan
Lecture 2Premises & Plant Layout Designing
Lecture 3Sanitation and Hygiene
Lecture 4Equipment Modules
Lecture 5Production Modules
Lecture 6Documentation
Lecture 7Quality Control
Lecture 8Product Complaint
Lecture 9Storage
Lecture 10Product Recall | Product Withdrawal | Types of Recall | Handling and Management of Product Recall
Lecture 11Pharmaceutical SOPs Management from regulatory perspective
Lecture 12Quality Risk Management | ICH Q9 | ISO 14971 | Principle of Risk Management 
Section 2Pharma and Biopharma Auditing - Understanding drug submission process, registration dossier, CMC auditing
Lecture 13Introduction to section
Lecture 14R&D Process & Introduction to drug discovery
Lecture 15Investigational New Drug Application (INDA)
Lecture 16New Drug Application (NDA) 
Lecture 17Basic concept and understanding of the Generic Drug
Lecture 18Abbreviated New Drug Application (ANDA) Filing 
Lecture 19Biological Licensing Application (BLA) 
Lecture 20Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 21Advance Learning on 505B2 Pathway
Lecture 22Chemistry, Manufacturing & Controls 
Lecture 23Evaluating Common Technical Document (CTD)
Lecture 24CMC Dossier & Compliance Management
Lecture 25Electronic Common Technical Document (ECTD)
Lecture 26Dossier Preparation 
Lecture 27Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 28Key Consideration for Drug Master File Preparation and Submission 
Lecture 29Practical Understanding on Drug Master File Preparation and Submission
Lecture 30Site Master File - Detailed Understanding 
Lecture 31Importance of effective dossier management
Lecture 32Discussion on 85 common deficiencies in CTD submission dossier
Lecture 33Certificate of Analysis
Section 3Plant Inspection
Lecture 34Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter 
Lecture 35Managing Data Integrity issues
Lecture 36GMP Audit Format
Lecture 37CAPA
Lecture 38Complete Response Letter | Key understanding | Management and Action Plan
Lecture 39RTQs | Response to Queries | How to handle Regulatory Queries