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Home All Courses CPGP Pharmaceutical GMP Professional Certification
4.8

CPGP Pharmaceutical GMP Professional Certification

1 alternative location(s) available

Course Overview

The Certified Pharmaceutical GMP Professional understands the good manufacturing practices (GMP) as regulated and guided by national and international agencies for the pharmaceutical industry. This covers finished human and veterinary drugs and biologics, ectoparasiticides, and dietary supplements (alternatively called nutraceuticals) where regulated as drug products, as well as their component raw materials (includes active pharmaceutical ingredients (APIs) and excipients), and packaging, and labeling operations. Employees who have obtained certification as a Pharmaceutical GMP Professional have a demonstrated, extensive, and proven knowledge of the quality system, ensuring that high-quality products are delivered to the consumer. With their breadth of knowledge, employees holding a CPGP can support nearly any aspect of your company’s business and deliver exceptional performance.  

1 alternative location(s) available

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5 Key Takeaways

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Will have a fundamental understanding of requirements and consequences of noncompliance of regulatory agency governance, including global regulatory framework, relevant regulations and guidelines, and mutual recognition agreements.

Will be able to understand, apply, and evaluate elements and requirements of a quality system. Will be able to understand and evaluate self-inspection, audits, and supplier management. Will be able to evaluate records, documents, and reports created within these quality systems.

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Will be able to understand, apply, analyze, and evaluate requirements, specifications, and data relating to laboratory systems, including relevant compendia for the United States, Europe, and Japan, investigations of atypical laboratory results, and instrument control and record-keeping. Must be able to apply and evaluate stability and sample retain programs. Will be able to apply requirements, specifications, and qualification and validation for construction and maintenance of facilities, utilities, and equipment. Evaluate automated or computerized systems, and apply business continuity plans, disaster recovery techniques, and change management.

Will be able to apply sampling plans and procedures for shipping and receiving materials, analyze inhouse storage, identification, and rotation of materials, and meet requirements for materials traceability and sourcing, including returned goods.

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Will have a thorough under-standing of sterile and nonsterile requirements of manufacturing systems and be able to analyze master and completed batch records, material control procedures, and contamination controls.

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See What’s Inside Our 2020 Catalog

Course Outline

1

Regulatory Agency Governance

  • Global Regulatory Framework
  • Regulations and Guidances
  • Mutual Recognition Agreements
  • Regulatory Inspections
  • Enforcement Actions
  • Regulatory Agency Reporting
  • Post-marketing changes
  • Regulatory reporting requirements
  • Product surveillance
  • Site Master File (SMF), Validation Master Plan (VMP) and Drug Master File (DMF) and Site Reference File (SRF)

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Quality Systems

  • Quality Management
  • Quality Unit (Site) Management
  • Risk Management
  • Training and Personnel Qualification
  1. Needs analysis
  2. Staff development requirements
  • Change Control and Management
  1. Pre-change analysis
  2. Post-change analysis
  • Investigations and Corrective and Preventive Action (CAPA)
  1. Trigger events
  2. Response actions
  3. CAPA feedback and trending
  • Audits and Self-inspections
  1. Audits processes and results
  2. Audit follow-up
  • Documents and Records Management
  1. GMP document system
  2. Records
  3. Record retention
  • Product Complaints and Adverse EventReports
  1. Product complaints
  2. Adverse events
  3. Event response
  • Product Trend Requirements
  • Supplier and Contractor Quality Management
  1. Supplier quality systems
  2. Supplier controls
  3. Supplier evaluation

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EDUCATIONAL PARTNER

ASQ - The American Society for Quality

The American Society for Quality (ASQ) is the world’s leading authority on quality. With more than 80,000 individual and organizational members, this professional association advances learning, quality improvement, and knowledge exchange to improve business results, and to create better workplaces and communities worldwide. Today, ASQ has become a global organization, with members in more than 140 countries. ASQ now has service centers in Mexico, China, and India, and has established strategic alliances with numerousorganizations to promote ASQ products and training. A rich history and bright future; we are ASQ, the Global Voice of Quality™. LEORON is an official educational partner for ASQ for number of EMEA countries.

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Who Should Attend?

This highly practical and interactive course has been specifically designed for:

Common job functions: Auditing, Inspection, Manager, Quality Assurance, Supervisor, Technician Common industries: Government, Medical Devices, Packaging, Pharmaceutical Manufacturing, Service

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FREQUENTLY ASKED QUESTIONS

Most of our public courses are delivered in English language. You need to be proficient in English to be able to fully participate in the workshop and network with other delegates. For in-house courses we have the capability to train in Arabic, Dutch, German and Portuguese.

LEORON Institute partners with 20+ international bodies and associations.
We also award continuing professional development credits (CPE/PDUs) for:
1. NASBA (National Association of State Boards of Accountancy)
2. Project Management Institute PDUs
3. CISI credits
4. GARP credits
5. HRCI recertification credits
6. SHRM recertification credits

The deadline to register for a public course is 14 days before the course starts. Kindly note that occasionally we do accept late registrations as well, but this needs to be confirmed with the project manager of the training program or with our registration desk that can be reached at +971 4 447 5711 or [email protected].

The course fee covers a premium training experience in a 5-star hotel, learning materials, lunches & refreshments, and for some courses, the certification fee and membership with the accrediting bodies.

Yes, we can provide discounts for group bookings. If you would like to discuss a discount on a corporate level, we will be happy to talk to you.

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