Pharmaceutical Good Manufacturing Practice
Improving Healthcare and Pharmaceutical Management
Course Description
WHY CHOOSE THIS TRAINING COURSE?
A robust quality system that meets the requirements of pharmaceutical regulators is an essential element of every good pharmaceutical manufacturing operation. This course will introduce participants to the essential features of a US Good Manufacturing Practice (GMP)-compliant quality management system as well as covering recent developments in pharmaceutical regulation. The duties of personnel in the production, quality control and quality assurance departments will be explained, together with requirements for GMP-compliant documentation and records. The expectations of regulators regarding the qualifications, experience and on-going training/development of personnel will also be covered. Special emphasis will be given to the relatively recent topic of pharmaceutical data integrity, including controls required over quality-critical electronic data systems. Participants will also be introduced to the concept and application of quality risk management in a GMP environment.
Course Methodology
The material used in the training course will be based on exercises as well as regional and international case studies. Participants will frequently work in pairs with one another as well as in larger teams.
Course Objectives
By the end of the course, participants will be able to:
- Explain the importance of Good Manufacturing Practices (GMP) in ensuring patient safety and drug efficacy
- Apply US-compliant pharmaceutical standards to enhance the current pharmaceutical quality management system within their own organization
- Find and continuously implement the current GMP requirements and updates frequently released by US authorities
- Implement pharmaceutical data integrity regulations
- Produce GMP-compliant documents, records and written procedures
- Prepare for regulatory inspections as well as internal and supplier audits
Target Audience
This course is designed for production and quality control professionals in the pharmaceutical manufacturing industry. It will be particularly beneficial for individuals responsible for compliance or quality assurance such as quality auditors, regulatory affairs professionals, production auditors, regulators, training and production managers, as well as anyone interested in effective GMP compliance tools and techniques. Professionals working with finished pharmaceuticals, combination products or devices will also gain insight on how to better structure their respective quality systems.
Target Competencies
- Good Manufacturing Practice
- Understanding Pharmaceutical Quality Systems
- Performing Pharmaceutical Audits
- Data Integrity
- Producing GMP documents
DAY ONE
Essential elements of Good Manufacturing Practices (GMP)
- • Historical background
- General GMP requirements (21 CFR 211)
- Organizational units
- Key roles
- Building management
- Facilities management
- Where to find current information and guidance
- International harmonization
- United States Pharmacopeia
- Quality risk management
Equipment, processes, and materials
- Validation master plan
- Validating processes: US Federal Drug Authority guidance
- Qualifying equipment: A risk-based approach
- Laboratory equipment
- Computerized data systems
- Good Automated Manufacturing Practices (GAMP) classification
Control of materials
- Specifications
- Approval
- Rejection
- Quarantine
DAY TWO
Documentation and the pharmaceutical quality system
- Pharmaceutical quality system (ICH Q10)
- Quality manual
- Standard operating procedures
- Analytical procedures
- Production records
- Equipment records
- Document control
- Personnel records
- Out-Of-Specification (OOS) investigations
- Out-Of-Trend (OOT) investigations
- Deviation reports
DAY THREE
Audits
- The audit process: Planning, documentation, and corrective actions
- Internal audits: Audit schedule
- Supplier audits
- Regulatory inspections: FDA audit observations
Pharmaceutical data integrity
- Data integrity definitions and expectations
- Data integrity risks in the analytical process
- Data integrity risks in computerized systems
- Examples of data system controls
- Extracts from FDA data integrity warning letters
CERTIFICATION
Successful participants will receive Peganix’s Certificate of Completion.
All attendees to a Peganix accredited course receive a Certificate of Accreditation acknowledging their training and their journey to New Skills, New Thinking. Independent research has verified that this recognition is highly valued by your employees.
Live Online / Virtual
Registered delegates can log in and join the live meeting. The online platform will not limit your participation, as you can engage on the platform via live chat text, audio, or video. All live meetings will be recorded and made available to all participants.
At any point, you’re not feeling too well to attend the in-person meeting you can simply log in at home and join live online.
- 22, 23 & 24 May 2024
- | Johannesburg, South Africa
- In-Person
- Virtual
Contact Us
- registration@peganix.com
- +2711 041 0181
- +2768 053 6221