Pharmaceutical Good Manufacturing Practice
Become acquainted with the best practices for implementing Good Manufacturing Practices — Guidelines for the application of Good Manufacturing Practices (GMP) in Pharmaceutical Manufacturing.

Summary
“Pharmaceutical Good Manufacturing Practice gives guidelines for the production, control, storage and shipment of pharmaceutical products”. It provides a comprehensive approach for a quality management system for those engaged in the manufacturing, packaging, testing, storage, and transportation of pharmaceutical finished products. Pharmaceutical Good Manufacturing Practice has its basis in other quality management systems, ensuring a smooth integration with those quality management systems. This course enables participants to learn about the best practices for implementing and managing a Good Manufacturing Practices (GMP) for pharmaceutical industry. The participant will learn the different components of a GMP, including the GMP quality manual, required procedures, records, Cleaning and contamination control, internal audit and continual improvement.

Who should attend?
• Members of a Quality team
• Professionals wanting to gain a comprehensive knowledge of the main processes of a Good Manufacturing Practices (GMP)
• Staff involved in the implementation of the GMP
• Staff involved in operations related to a GMP
• Auditors

Learning objectives
• To Understand the implementation of a Good Manufacturing Practice
• To Understand the relationship between a Good Manufacturing Practice and compliance with the requirements of different stakeholders of the organization
• To Know the concepts, approaches, standards, methods and techniques allowing to effectively manage a Good Manufacturing Practice
• To acquire the necessary knowledge to contribute in implementing a Good Manufacturing Practices (GMP).

Course Agenda
First Day
Section 1 – Introduction to the Regulations
• What are the GMPs
• Intro to the FDA
• Intro to the FD & C
Section 2 – Other Regulatory Agencies
• EU and other regulations
• Importance to our manufacturing
Section 3 – Organization and Personnel Roles and Responsibilities
• Department Roles/Functions
• Interactions
• Training
• Change Control
Second Day
Section 4 – Facilities & Equipment
• Types of Facilities – Solid Dose, Aseptic, Biologic, API
• Facilities and Equipment – the role they play
• Flows – Material, Air, Personnel
• Lighting, Plumbing, & Containment/Contamination
Section 5 – Vendors and Materials Control
• Classification of materials according to function
• Material specifications
• Vendor Auditing – qualifying, and controlling suppliers and contractors
• Control of incoming materials
• Container Closure and other GMP functions
• What the regulations require for reduced testing
Section 6- Process Control: “Master Batch Records and Validation”
• The Validation Master Plan
• Review and Approval of Master Records
• Converting the Master Record to a Batch or History Record
• Predicate rules and Part 11 – What are they really
• Another new paradigm-Process Analytical Technology (PAT)
Section 7 – Packaging and Labeling
• Why is packaging and labeling is so important?
• Controlling Labels and other Printed Materials
• Examining and storing Packaging & Labeling Materials
• Controlling labeling operations
Section 8 – Validation (applying CGMPs)
• Qualification v. Validation
• Protocol Development
• Types of Validation
• Executions
• Final Reports
Third Day
Section 9 – Laboratory Controls
• Sampling
• Analytical methods-Scientific Basis, Approval, & Validation
• Pharmacopeias
• Methods Validation Requirements
• Equipment Qualification Requirements
• Controlling Reagents & Reference Standards
• Laboratory Data-Notebooks, LIMS, & Disks
• Equipment Controls
• Using a Contract Laboratory
Section 10 – Product Release and Distribution
• QA Responsibilities in Product Release
• Why perform testing on finished products?
• Batch Record Review
• Recalls
Section 11 – Records – Reports – Investigations
• Storing Documents and Retains
• When Things Go Wrong
• Getting to the Root Cause
Section 12 – Wrap Up
• Consent Decree Case Studies
• Questions & Answers

Training Methodology
• This training is based on both theory and practice:
• Sessions of lectures illustrated with examples based on real cases
• Review exercises to assist the exam preparation
• Practice test similar to the certification exam

Fee: N75,000 per participant (cover Training, Material, Lunch, Venue, Equipment and Certificate ). Discount of 10% for 4-9 participants, 15% for 10 and above.

Duration: 3 Days
Date: 25-27 October, 2017

Venue: DU&T Hall / as may be agreed

Registration Details: DU&T Consulting, 0016102526 GTBank Plc

Enquiry: 08033746074, 08182704266 or amaka@dutconsulting.com

DU&T Consulting, 5 Afisman Drive, Anifowose, Ikeja, Lagos. www.dutconsulting.com