SELF-PLACED COURSE (Do not Wait ! Start Now !)

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 Course Duration: 3 Hrs.  (Online)

• gmp training courses Class Room Link / Training Link will be shared through your registered email after the completion of the fee payment.
• Participants need to go through the Each chapter and complete the final assessment.
• Total Chapter: 1 to 20
• Duration of the Program: (3 Hrs.) One Month. 
• Examination should be completed within One Month.  
• Course materials can be downloaded from the classroom.
• Upon completion of the course, participants gain the INTERNATIONAL CERTIFICATE

• Pharmaceutical professionals (QA/QC, manufacturing, R&D) gmp pharmaceutical industries.
• Regulatory affairs specialists
• Compliance officers
• Engineers and technicians in pharma production
• Healthcare and biotech professionals
• Bio-Technologist
• Microbiologist
• Chemist

Overview:

Our Good Manufacturing Practice (GMP) Pharmaceutical Course are designed to ensure that pharmaceutical companies adhere to the highest standards of quality, safety, and compliance throughout the manufacturing process. We provide comprehensive solutions to help pharmaceutical organizations establish and maintain GMP compliance, thereby safeguarding the integrity and efficacy of their products.

Good Manufacturing Practices (GMP) in pharmaceutical industries are critical to ensuring a medical product is quality-assured and fit for its intended use. Achieving both protects the public from substandard products and helps to maintain and/or improve the health and well-being of patients.

Basic GMP principles are specified by the World Health Organization (WHO) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S). Many countries have their own GMP guidelines, which are often based on the WHO standard. Manufacturers must comply with the regulatory requirements of the countries where they produce and market their products.

This online course provides an overview of essential GMP principles and requirements. It covers key principles of the WHO and PIC/S standards and will equip participants with a broad, foundational understanding of GMP.

Key Components:

• GMP - Medicinal Products (USP)
• GMP - Active Pharmaceutical Ingredients (USP)

Quality Management, Personnel, Buildings & Facilities, Process Equipment, Documentation & Records, Materials Management, Production & In-Process Controls, Packaging And Identification Labeling, Storage & Distribution, Laboratory Controls, Validation, Change Control, Rejection & Re-Use Of Materials, Complaints & Recalls, etc...

• GMP - Sterile Pharmaceutical Products (WHO)

Quality control, Sanitation, Manufacture of sterile preparations, Sterilization, Terminal sterilization, Aseptic processing and sterilization by filtration, Isolator technology, Blow/fill/seal technology, Personnel, Premises, Equipment, Finishing of sterile products.

• GMP Compliance Assessment:

Conduct thorough assessments of current manufacturing processes and facilities to identify gaps in compliance with GMP regulations.

Provide detailed recommendations and action plans to address deficiencies and enhance GMP compliance.

• GMP Documentation and SOP Development:

Assist in the development, review, and optimization of Standard Operating Procedures (SOPs) and documentation required for GMP compliance.

Ensure alignment with regulatory requirements and industry best practices.

• Facility Design and Validation:

Offer expertise in designing and optimizing pharmaceutical manufacturing facilities to meet GMP standards.

Conduct validation studies for equipment, processes, and facilities to ensure they meet regulatory requirements and produce consistent, high-quality products.

• Training and Education:

Develop customized training programs to educate personnel at all levels on GMP principles, procedures, and regulatory requirements.

Empower employees to understand their roles in maintaining GMP compliance and fostering a culture of quality and accountability.

• Quality Control and Assurance:

Implement robust quality control measures to monitor and evaluate product quality throughout the manufacturing process.

Conduct regular audits and inspections to ensure adherence to GMP standards and identify areas for improvement.

• Regulatory Affairs Support:

Provide guidance and support in navigating complex regulatory requirements governing pharmaceutical manufacturing.

Assist in preparing regulatory submissions, responding to inquiries, and managing interactions with regulatory authorities.

• Continuous Improvement Initiatives:

Establish systems for ongoing monitoring, measurement, and improvement of GMP compliance.

Implement corrective and preventive actions (CAPAs) to address non-conformities and prevent recurrence.

Benefits:

• Compliance Assurance: Ensure compliance with regulatory requirements and industry standards, minimizing the risk of regulatory sanctions and product recalls.
• Product Quality: Maintain consistently high-quality pharmaceutical products that meet safety, efficacy, and purity standards.
• Risk Mitigation: Identify and mitigate risks associated with manufacturing processes, facilities, and product quality, protecting patient safety and brand reputation.
• Operational Efficiency: Streamline manufacturing processes and reduce operational costs by optimizing workflows and resource utilization.
• Market Access: Facilitate market entry and expansion by demonstrating GMP compliance to regulatory authorities and customers.
• Customer Confidence: Build trust and confidence among healthcare professionals, patients, and stakeholders by delivering safe and effective pharmaceutical products.

Target Audience: This course for anyone who works in medical products production and quality assurance. This includes manufacturers and regulatory authorities..

Assessment: Participants may be evaluated through quizzes, and a final examination to ensure comprehension and application of the course material. 

Outcome: Participants completing the GMP Pharmaceutical Training Program will be equipped to plan, conduct, report, and follow up audits effectively. They will gain the INTERNATIONAL CERTIFICATE and insights into the GMP Pharmaceutical International standard, helping organizations achieve and sustain a high level of quality management. Successful participants will contribute to the continual improvement of their organization's QMS and support the overall goal of delivering products and services that meet or exceed customer expectations.

Course Duration: 

• SELF-PLACED COURSE (Do not Wait ! Start Now !)

SELF-PLACED COURSE ( Do not Wait! Start Now !)

• After fee payment we will share the Self-Placed Course Link to your registered email address.
• After receiving mail join the class and start learn and complete the assignment and examinations.
• U-TECH INTERNATIONAL certificate of “GMP Pharmaceutical” will be issued to participants only after successful completion based on written examination 

Training Link: Will be shared through your registered email after the completion of the fee payment.

• Participants will be assessed through a 50 marks MCQ type online examination (open book) at the end of the course
• Minimum passing% criteria: 60%.( 30 Marks)

• U-TECH certificate of “GMP Pharmaceutical” will be issued to participants only after successful completion based on performance during the course and in written examination 
• Others who have not successfully completed the course will be issued a certificate of attendance.

Training Link: This will be shared through your registered email after the completion of the fee payment.

Course materials will be provided for all participants