NUSAGE Pharmaceutical and Biotechnology Training Courses

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Dec 1, 2012 (4 years and 8 months ago)

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NUSAGE Pharmaceutical and Biotechnology Training Courses





DISTRIBUTION, MARKETING, ADVERTISING AND PROMOTION OF PHARMACEUTICALS AND MEDICAL DEVICES INTERNATIONALLY

Objective:
The objective of this course is to provide an overview to technical professionals, particularly those in Regulatory Affairs and Quality Assurance, on
the general legal requirements and issues associated with distribution, marketing, advertising, and promotion of pharmaceutical and medical
device products internationally.

Description:
This course provides a comprehensive discussion of the basis of regulations on distribution, marketing, advertising, and promotion of
pharmaceutical and medical device products internationally.
The course will cover the roles of different parties on the commercial side, such as marketing authorization holder, distributor, sales and marketing
team, and on the regulatory agency side, such as health authorities and trade authorities. General requirements from major reference countries
will be discussed, as well as a sample of Asian countries, including Singapore.
While the fundamental logic from country to country is usually quite similar, specific requirements are subject to ongoing updates. This course will
also instruct the attendees on the significance of regulatory intelligence when planning for an international product launch.

Course Outline – Overview:

• The roles of marketing authorization holder, distributor, and sales and marketing team
• Legal jurisdiction between drug/device regulatory agencies and trade agencies
• Legal requirements on distribution
o Import / export of products in major reference countries: US, EU, Australia, Canada
o Import / export of products in Singapore
o Good Distribution Practices in Singapore
• Legal requirements on Advertising and Promotion
o US
o Singapore
o General rules for other countries
• Case Study of a drug ad and a drug packaging
• Off-label promotion
• Medical education
• Other types of drug usages.
o Product sampling
o Pharmacy compounding
• Case Study of FDA enforcement
o Warning letters
o Consent decrees
• Internal controls and policing of advertising and promotion
o Sales representatives
o Marketing events and programs
• Performing regulatory intelligence

Learning Outcomes:
Upon completion of this course the attendees will be able to:

1. Understanding the fundamentals of legal logic behind distribution, marketing, advertising and promotion of drug and medical device products
2. Understanding the fundamentals of roles and responsibilities amongst different commercial parties as well as regulatory parties
3. Understanding the fundamentals of controlling over off-label usages, personnel
4. Understanding the importance of regulatory intelligence




NUSAGE Pharmaceutical and Biotechnology Training Courses




FUNDAMENTALS OF MEDICAL DEVICE REGULATORY AFFAIRS

Objective:
The objective of this course is to provide an overview to technical professionals, particularly those in Research & Development and Regulatory
Affairs, on the general legal requirements to bring a medical device product to market – whether it is the creation of a new product, or
import/export of a product to a new market.
Description:
This course will discuss medical devices in major international reference environments and select countries in Asia, medical device definitions and
classifications. The course will discuss the major pre-marketing regulatory challenges and potential solutions in key Asian markets.
Advanced products such as combination products are interpreted differently by different agencies, and there tends to be more disparity among
Asian countries compared to more mature Western agencies. This course will discuss some of the challenges with such advanced products.
Course Outline:
• Introduction to RA – what is the role of RA
• Introduction to major global reference regulations and harmonizations
o US
o Europe
o Japan
o Australia
o Canada
o GHTF
• Overview of regulatory environment in major Asian reference countries:
o AHWP, ASEAN, ARPA
o Singapore
o China
o Hong Kong
o India
o Future trends in regulatory development
• Pre-market requirements
o Background
o Classifications
o GMP
o Conformity assessment
• Advanced products:
o Combination products
Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Understand major global reference regulations and harmonization efforts for medical devices
2. Understand regulatory environment in key Asian markets for medical devices
3. Understand general pre-market requirements
4. Understand the legal logics behind the definition and regulation of advanced products






NUSAGE Pharmaceutical and Biotechnology Training Courses




FUNDAMENTALS OF PHARMACEUTICAL REGULATORY AFFAIRS
Objective:
The objective of this course is to provide an overview to technical professionals, particularly those in Research & Development and Regulatory
Affairs, on the general legal requirements to bring a pharmaceutical product to market – whether it is the creation of a new product, or
import/export of a product to a new market – and maintaining it afterwards.
Description:
This course will discuss medical devices in major international reference environments and select countries in Asia, medical device definitions and
classifications. The course will discuss the major pre-marketing regulatory challenges and potential solutions in key Asian markets.
Advanced products such as combination products are interpreted differently by different agencies, and there tends to be more disparity among
Asian countries compared to more mature Western agencies. This course will discuss some of the challenges with such advanced products.
Course Outline:
• Introduction to RA – what is the role of RA
• Introduction to major global reference regulations and harmonizations:
o US
o Europe
o ICH
• Overview of regulatory environment in major Asian reference countries:
o ASEAN
o Japan
o Singapore
o Future trends in regulatory development \
• Classification of drugs and formulations
• Pre-market requirements
• Authorization procedures for drug products
• Quality systems and regulatory inspection process
• Post-market requirements and compliance
• Advanced products:
o Orphan drugs
o Named-patient drugs
Learning Outcomes :
Upon completion of this course the attendees will be able to:
1. Understand major global reference regulations and harmonization efforts for pharmaceuticals
2. Understand regulatory environment in key Asian markets for pharmaceuticals
3. Understand general pre-market and post-market requirements
4. Understand the legal logics behind the definition and regulation of advanced products







NUSAGE Pharmaceutical and Biotechnology Training Courses




COMPARISON OF GMPS FOR PHARMACEUTICALS, APIS, AND MEDICAL DEVICES
Objective:
This course provides an overview of the differences of Good Manufacturing Practice (GMP) requirements between pharmaceuticals, active
pharmaceutical ingredients, and medical devices. Learning the differences will allow professionals from the medical device and pharmaceutical
industries in Singapore to better cross-utilize resources, for example, persons with experience from one industry may adapt quicker to another
industry.
Description:
This course provides an overview of the differences in legal basis and GMP inspections between medical device manufacturers and pharmaceutical
manufacturers that formed some of the fundamental differences in GMP enforcement and adaptation. The course will use US FDA and European
Union regulations as the basis for the discussions. The US FDA and the EU are considered two of the most influential reference agencies in the
world.
The course will explore differences and similarities between these GMPs as well as show how they relate to other quality systems, regional
regulations, and guidance documents. Examples include ICH, GHTF, ISO particularly ISO 13485 as well as European quality requirements.
Course Outline:
• Introduction to Quality and Compliance Concepts
• Differences between Medical Devices and Pharmaceuticals
• Scope of the GMPs and the Quality Cycle
• Standards of Quality
• The Shifting Paradigm to Focus on Customer and User Satisfaction – The Quality Systems Approach
• Comparison of Definitions and Terms
• Comparison of Personnel and Management Expectations
• Comparing Design Requirements
• Comparing Master Records
• Comparing Equipment Controls
• Comparing Material and Incoming Controls
• Comparing the Control of Processes
• Packaging and Labeling Comparisons
• Laboratory Controls and Device Evaluation
• Holding, Distribution, & Returns
• Problem Solving-Deviations, Complaints, and CAPA
• Part 11
• Current Trends
• Review and Wrap-up
Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Understand the major differences between medical device and pharmaceutical GMPs, from the standpoint of written regulations, enforcement,
and compliance
2. Think about how the industries in Singapore can better share GMPresources





NUSAGE Pharmaceutical and Biotechnology Training Courses




GMP FACILITY DESIGN WITH GOOD ENGINEERING PRACTICE
Objective:
The objective of this course is to understand the approach to GMP Facility Design and how to employ Good Engineering Practice (GEP) as one of
the tools to aid the design process.
This course provides an overview of the design process, criteria and good practices like GEP and “risk-based approach” for GMP Manufacturing
Facilities with clear future Qualification and maintenance in mind.
Description:
The successful delivery of regulated manufacturing facilities poses significant challenges to manufacturers, engineering professionals, facility
design/construct contractors and equipment suppliers. A systematic approach to Process/Facility Design is one of the foundations to a “fit for
intended use”, compliant and cost-effective operating site. The course steps through the design definition, scope, applying key criteria, clean design
principles to develop a strong front end design package.
The last few years have seen several initiatives to best use of resources whilst being cost effective and compliant with regulatory requirements.
These initiatives are consensus with inputs from industry, ISPE, ASTM, FDA, ICH and so on. This course applies some of the initiatives and other
tools to enhance the facility design process:
• GEP – ISPE has released the good practice guide on GEP and its principles are promoted in ASTM E2500 and ISPE’s “Science and Risk-
Based approach for the Delivery of Facilities”, to name a few. The course applies these principles, methods and standards to the design
process.
Advantages are clear defined deliverables, avoiding the “re-inventing the wheel” syndrome and reducing equipment qualification burden.
GEP – once established is for the long term, saving resources, time and cost
• Risk-based approach – applying a rational approach to emphasize on critical process parameters.
• Project quality system – to enhance the communication and design deliverables between Client and Contractor
Therefore, the course participants will learn the key criteria and tools to Process/Facility Design illustrated with case studies to develop a strong
front-end design package. The standards and documents generated are transportable to the Qualification process.
Course Outline:
• Overview of regulatory and statutory requirements to Facility & Equipment
• Good Engineering Practice – key concepts, common practices, standards, engineering specifications. Examples of Drawing/Equipment
Control, Material of Construction, Piping Specifications.
• Risk-based approach – with respect to engineering and facility design.
• Facility/Process Design – Life Cycle Model, Industry Trend, User Requirement Specification (examples).
• Process Design – Process map, URS, Pre-qualification documentation, Clean Design principles, Case Study illustration.
• Facility Design – Building, Room Classifications, Layouts (People. Material & Equipment Flow), Utilities, Cost Estimates, Case Study
illustration
• Case Studies – Critical Utilities (Purified water system/WFI/Steam), Liquids/Cream Facility, Solid Dosage/Liquids Facility
• Quiz and group participation
• Course Handouts – some templates and examples to help you with implementation.
Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Gain an understanding of a practical approach to process and facility design and development of a design “front-end” package
2. Gain an understanding of the application of Good Engineering Practice
3. Understand the pre-requisites to a smooth Equipment Qualification process, operations and maintenance.



NUSAGE Pharmaceutical and Biotechnology Training Courses




CLEANING VALIDATION
Objective:
As a critical component to a compliant validation program, this course provides an overview of principles and regulatory requirements behind
cleaning validation. More specifically, this course will address cleaning validation in pharmaceutical plants.
Description:
Both the theoretical basis and practical applications of the validation process will be discussed. Some of the more common mathematical and
statistical treatments of validation data will be presented. Because of the tremendous effort that can be expended in conducting validation studies,
efficiency of experimental design and documentation will be stressed throughout the discussions and case studies.
This course provides participants with an understanding of the essential steps for the proper design and integration of pharmaceutical process and
cleaning validation for API products. It includes how to establish proper design criteria and specifications to form the basis of process and cleaning
validation design and compliance elements required for international cGMP compliance
Course Outline:
• Cleaning Validation Basics
• Elements of a Cleaning Validation Program
• Specific cleaning aspects of typical API processes
• Strategies and Approaches for Cleaning Validation
• Sampling Techniques and Methodology
• Cleaning and Sanitizing Agents and Methods
• How to Establish an Acceptable Residue Limit
• Cleaning Validation - Microbial Control
• Post Validation Monitoring of Cleaning Process
• Recommendations
• Regulatory concerns and requirements
Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Gain an understanding of the principles of cleaning validation
2. Gain an understanding of current regulatory perspectives from the US FDA, EU, and PIC/S
3. Gain an understanding of key cleaning validation concepts, such as sampling, cleaning, sanitizing, residue limits, microbial control
4. Gain an understanding of post-validation control of the cleaning process











NUSAGE Pharmaceutical and Biotechnology Training Courses




ANALYTICAL METHOD VALIDATION
Objective:
To convey a clear understanding of regulatory agency expectations and knowledge of the elements of an effective validation program. Students will
gain expertise in writing protocols and reports and developing acceptance limits for assay validation. This course provides insight on how to avoid
conflict validation pitfalls and ability to distinguish compliant from non-compliant validation activities.
Description:
One of the most critical factors in developing pharmaceutical drug substances and drug products today is ensuring that the analytical methods that
are used to analyze the products generate meaningful data. The FDA, USP, and the ICH have each recognized the importance of analytical method
validation to the drug development process and have increased method validation requirements in recent years.
Both the theoretical basis and practical applications of the validation process will be discussed. Some of the more common mathematical and
statistical treatments of validation data will be presented. Because of the tremendous effort that can be expended in conducting validation studies,
efficiency of experimental design and documentation will be stressed throughout the discussions and case studies.
Course Outline:
• Method Validation Background
• ICH/USP Validation Requirements
• Acceptance Criteria
• Method Validation vs. Method Purpose
• Method Validation Overview
• Method Validation Process and Statistics
• Bio-Analytical Method Validation
• Method Transfer Process
• Revalidation and Method Update
• Technology Changes
• Protocols /reports and Related Documents
Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Gain an overview of the background and history of method validations
2. Gain an understanding of method validation requirements per ICH and US Pharmacopoeia (USP), such as the classification of methods (e.g.
assay, identity) and various characterizations (e.g. accuracy, precision, specificity, etc.)
3. Gain an understanding of how to define the acceptance criteria, including discussions on USP references, process and statistical techniques.
4. Gain an understanding of analytical method transfer requirements, that is, transferring a validated method between sites.
5. Gain an understanding of bioanalytical method validation based on the FDA guidance
6. Gain an understanding of the regulatory resources that relate to method validations, transfers, and related requirements








NUSAGE Pharmaceutical and Biotechnology Training Courses




COMPUTERIZED SYSTEM VALIDATION
Objective:
To learn to establish validation programs; acquire understanding of the regulatory requirements and expectations for the validation of computer
systems used in pharmaceutical and biological industry; learn and understand the process and methodologies on computer system validation and
be able to apply the knowledge and principles to specific systems and cases.
Description:
This course is designed to provide an overview of the various aspects of computer systems validation and related validation documents and to
provide the basis for compliance and implementation. The course addresses the rules, tools, and techniques to develop and implement a validation
program or to validate a specific system. The course provides the principles for computer validation and offers a framework and the methodologies
to conduct validation projects.
The emphasis is on the most recent rules and techniques focusing in the relevant regulations, the system life cycle including requirements,
design/build, testing, qualifications and maintenance, 21 CFR Part 11 Electronic Records and Electronic Signatures and the journey this regulation
has taken, vendor audit, acquired and developed systems, retrospective validation, validation master plan, the validation project, risk assessment
and management, SOPs, requirements documentation, the traceability matrix, and related FDA Guidance documents.
Course Outline:
• Validation Overview
• Regulations and Regulators
• GAMP (Good Automated Manufacturing Practices)
• Qualifications, IQ/OQ/PQ
• 21 CFR, 11 Electronic Records and Electronic Signatures
• Risk Assessment and Management
• The System Life Cycle and Validation Strategies
• Vendor Audit
• Validation Plan and Project Management
• Retrospective Validation
• Spreadsheet Validation
• SOPs and Training
• Case Studies - Validation Requirements for
• Applicative Software
• Automated Spreadsheet Calculation Templates
• Computerized Equipment
• Computerized Laboratory Systems (LIMS, Chromatography Systems)
• MRP and ERP Systems
• Automated Control and Monitoring Systems
• Computer Network Qualification
Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Understand the various regulations and guidelines from regulatory bodies and industrial bodies such as 21 CFR 11, GAMP, Annex 11
2. Understand all the elements in a System Life Cycle approach
3. Understand the different classifications and types of computer systems, from the simple GAMP Class 1 systems to complex, bespoke Class 5
systems; from personal computer-based systems to industrial PLC systems.




NUSAGE Pharmaceutical and Biotechnology Training Courses




EFFECTIVE QUALITY ASSURANCE – AUDITS, ANNUAL REVIEWS, EVENTS HANDLING, AND CAPA
Objective:
To have an understanding of current QA topics in post-market maintenance of pharmaceutical products, which are of key importance for QA
management and personnel to consider.
Description:
This course provides an understanding of the principles and practice of pharmaceutical quality assurance and control and of specific topics, which
have become important because of regulatory interest or recent technological achievements.
This course provides: an understanding of the basic principles and practice of the QA function in a commercial manufacturing environment,
covering their role during product design, production, storage and distribution, with the role during production being addressed in particular detail,
consisting of reviews, first of broad current quality issues including major regulatory agency’s activities, and then the
QA aspects of a number of specific issues including: handling of laboratory controls, validation (equipment, processes, computers, cleaning and test
methods), label and labeling, water systems, change control, electronic records and signatures, deviations and discrepancies, (including OOSs),
regulatory agency inspections, internal and supplier audits, vendor and contract supplier qualification, annual product reviews, and training. The
QA aspects of stability program operation and also documentation are presented as well.
Course Outline:
• Quality Function
• QA’s Role in Production
• Laboratory Controls
• Label and Labeling Control
• QA Aspects of Water
• Change Control
• Deviation/Discrepancy Handling
• Electronic Records and Signatures
• Regulatory Inspections and Their Impact on QA
• Internal and Supplier Audits
• Corrective Action and Preventive Action (CAPA) program
• Training Programs and Their Impact on QA
• Vendors and Contract Suppliers
• Annual Product Reviews
• QA Aspects of Stability Programs
• QA Aspects of Documentation

Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Understand the Quality Function, as well as the role of QA and QC units in manufacturing / production
2. Understand essential QA programs, such as change control, deviation handling, internal and supplier audits, CAPA
3. Understand the responsibility of vendors and contract suppliers, and QA’s role in managing these relationships
4. Understand stability programs
5. Understand documentation practices





NUSAGE Pharmaceutical and Biotechnology Training Courses





STERILIZATION – STEAM, ETHYLENE OXIDE

Objective:
To have an understanding of two of the most common and fundamental sterilization methods for medical devices and pharmaceutical products –
steam sterilization and ethylene oxide sterilization.


Description:
Sterilization is designated as a special validated process by both ISO and US FDA, having unique requirements. Steam sterilization and ethylene
oxide sterilization are two of the most common and fundamental sterilization methods for medical devices and pharmaceutical products. Besides
US FDA requirements, steam sterilization is governed by ISO 17665, and ethylene oxide sterilization by ISO 11135. This course discusses
fundamentals of microbiology theories pertaining to sterilization, regulatory requirements, validation, equipment, and re-validation.

This is an advanced course aimed at senior technical, regulatory, design and quality practitioners


Course Outline:

• Overview of regulatory basis on steam and ethylene oxide sterilization methods:
o US FDA
o US Pharmacopoeia
o ISO 17665
o ISO 11135
• Application of sterilization methods in medical devices and pharmaceutical products
• General requirements
• Fundamentals of microbiology theories pertaining to sterilization
• Detailed explanation of steam and ethylene oxide sterilization mechanisms, equipment, materials, and monitoring devices
• Validation
• Ethylene oxide residues
• Management of routine sterilization cycles, product release and process deviations
• Re-validation


Learning Outcomes:
Upon completion of this course the attendees will be able to:
1. Understand the fundamentals of microbiology theories pertaining to sterilization
2. Understand the acting mechanisms with steam and ethylene oxide sterilization methods
3. Understand the regulatory requirements
4. Understand validation of sterilization methods
5. Understand key safety issues such as ethylene oxide residues