Modern Validation Technology Boot Camp

Transcription

1 2018 Modern Validation Technology Boot Camp Modern Process validation Risk based Modern cleaning Validation Facility and equipment qualification? Risk analysis Advanced Topics Protocols and SOPs 6700 TransCanada, Pointe-Claire, Quebec, Canada H9R 1C2

2 Boot Camp Objectives Stay Current This boot Camp has been designed to provide a strong understanding of Validation in view of QbD concepts, objectives and techniques, that are the current thinking of FDA, EMA and Health Canada, we have provided several real study cases to link the theory and techniques to practice. The course was designed for the pharmaceutical professionals with the responsibilities in product design, operation, management of the quality system, compliance and CMC application. They will learn all about the QbD requirement and how it relates to ICH Q8 and Q9 and how to integrate the different components effectively for a complete robust manufacturing system and relate it to Q 10 and 11. By using QbD a new quality paradigm was born that will provide more robust processes as well as products, and true scientific understanding of the risk based critical quality attributes that can be properly controlled to continuously provide for a desired quality product that will meet its desired clinical performance. Who will benefit? Pharmaceutical, companies, who have some GMP background (at least 6 months) and need a step-by-step, understanding of QbD in pharmaceutical manufacturing: QbD project Managers QbD team R&D Regulatory Affairs Production managers Analytical Development Compliance Auditing QA and QC Validation This course is also of interest to Equipment Contractors and Consultants. Learning Objectives Understand the Basic Fundamentals and Approach of Validation Understand Risk-Based GMP Compliance and FDA, ICH and ASTM Approaches Review Strategies for Defining Risk, Risk Factors and Risk Prioritization Use QbD to Mitigate Product Risk in Manufacturing Operations Understand the FDA guideline and how to apply the concepts How to develop design space, and define CPP Understand the Connection Between QbD and Process Analytical Technology (PAT) and laying the foundations for control strategy. How to use design of Experience (DoE) Implement the Concept of Continuous Improvement

3 Distinguished Speakers Ady Sadek, M.Sc., P.Chem is president of progamma Science Corporation, previously he spent 25 years in the pharmaceutical industry with BioResearch, Schering-Plough and Novartis Pharmaceuticals, holding positions such as Manager of Analytical & Development Labs, Director of Quality and Director of Quality Audit. He holds two master degrees in Organic and analytical chemistry. Ady s vast experience in process design and validation started in 1981, when developing new formulations for FDA submissions. He has been involved in many validations and his experience extends from formulation development to scale up commercial batches and technology transfer. He provides strategic QbD and PAT projects management throughout Canada, USA and Europe to several multinationals. David Tozer, Ph.D., CQE, Six Sigma black belt is president of Qualitiqua, Dr. Tozer has more than 25 years of experience in Quality management, in the pharmaceutical and software industries, after earning a Ph. D. in physics at the University of Waterloo. He then worked in the quality field for many years in the pharmaceutical, defence, aerospace, medical, manufacturing, and software industries. In industry, Dr. Tozer successfully led teams of people to improve their organizations using the Six Sigma methodology. He is an ASQ CQE and teaches quality courses for the ASQ and a joint ASQ McGill university program. Dr. Tozer trained over 500 people in various topics in the quality field.. Certificate awarded to participants

4 Course Content Module 1 Introduction Current regulatory requirements for process validation for pharmaceuticals and biopharmaceuticals as per HPFB, and New FDA and EMEA. Module 2 Validation Essentials New Validation Basics and Regulatory Requirements Definitions ;Validation Support Programs,Documentation, SOPs PPQ Protocols, The Validation Life Cycle ; Change Control and Validation How Much is Enough! Module 3 New Process Considerations Process design Process qualification Continued Process Verification Process variables, how to control your process? How about grandfather product validation? Module 4 Validation Master Plan What are the important elements in the validation master plan Protocol and Report Format? Module 5 Process Critical Parameters for nonsterile products Critical Parameters to be considered for tablet manufacturing; process optimization and troubleshooting. What are the critical considerations for product and process scale-up? Module 6 Role of Blend Uniformity and process validation Importance of Raw Material Characterization Sample Size and Procedures o Acceptance Criteria and analytical procedures Blend Uniformity Analysis Recommendations for Simple Dosage Forms Blend Uniformity Analysis Recommendations for Complex Dosage Forms and Complex Processes

5 Module 7 Case study How to avoid serious mistakes? Examples Module 8 How to Organize an efficient Validation file Style and format for validation file How to write a validation protocol? Presenting Validation Data How to make the validation file a working document? Advanced Topics Module 9 Statistical Tools in Validation Why Statistical Tools? The Basic application of different tools and their use in Process Validation. How to design experiments effectively for Process validation? Process Capability Studies Module10 Establishing the minimum process capability for a pharmaceutical manufacturing process Establishing valid sampling and testing specifications Establishing valid Release specification How to correct process mean and process variability for their uncertainty Examples Module11 Process Analytical Technology (PAT) - changing the validation Paradigm Module12 Techniques of Risk analysis and process validation The new ICH Q9 Application of risk assessment in Validation Examples

6 Module 13 Cleaning Validation Fundamentals of Cleaning Validation History and evolution of cleaning validation Key components of a cleaning validation Cleaning validation lifecycle Module 7 How to Organize an efficient Validation file Style and format for validation file Module How 14 to write a validation protocol? Presenting Validation Data Regulatory How Requirements to make the for validation Cleaning file Validation a working document? GMPs as related to cleaning validation HPFB,FDA and EU requirements and industry standards Inspection guidelines related to cleaning Module Recent 8 regulatory trends and issues Statistical Tools in Validation Advanced Topics How to establish worst case condition for shared equipment and products? Why Statistical Tools? Module The Basic 15 application of different tools and their use in Process Validation. How to design experiments effectively for Process validation? Process Capability Studies Residue sampling and Assessments Module Sources 9 of contamination or residues QbD: Development Design of of Experiments suitable analytical (DoE) methods What Calculation is design of residue of experiments? limits, scientifically justifiable Maximum Advantages allowable of design carryover of experiments (MACO) (DoE) and vs. minimum one factor allowable at a time detection approaches limit (MADL) The HPLC, importance TOC and of other pre-doe analytical experimentation methods and planning Factors, Visually ranges, clean number as criteria of levels, responses Determine Commercial how DoE clean software is clean Module 10 Module Establishing 16 the minimum process capability for a pharmaceutical manufacturing process Establishing valid sampling and testing specifications Establishing valid Release specification How to correct process mean and process variability for their uncertainty Examples Risk-based approach to cleaning validation FDA s risk-based approach to cleaning validation activities Module 11 Using risk management principles when choosing validation targets Equipment grouping and residue grouping Dirty hold times vs. Clean hold times) Risk Analysis of Cleaning Validation Process Analytical Technology (PAT)- changing the validation Paradigm Module 12 Techniques of Risk analysis and process validation The new ICH Q9 Application of risk assessment in Validation Examples

7 Facility and Equipment Qualification Module 17 Qualification Master plan Equipment and Facility Master Plan model: Structure Areas of emphasis: Infrastructure and Facilities Equipment Module 18 DQ, IQ,OQ and PQ Design Qualification Risk analysis Documentation Required Installation qualification (IQ) Operational qualification (OQ) Performance qualification (PQ) Module 19 Facility Validation Specification Phase Planning FATs and PDI Commissioning What are the 20 tools of Facility validation? Module 20 Validation of Utilities: Gas systems for sterile operations Steam systems Vacuum systems Electrical systems

8 progamma Science Corporation On Line New Validation Technology BootCamp Please write down the date you would like to start 2018 / / Please return the completed registration form to: By Fax:+1(514) eregistration Form By Phone:+1(514) infoteck@progamma.ca progamma Science Corporation 6600 TransCanada, Suite 125, Pointe Claire Quebec, Canada H9R 4S2 Please Register the : Name: $ Delegate (1): Delegate (2): Delegate (3): Delegate (4): SUBTOTAL $ GST $ * Only for Quebec residence PST* $ Total: $ Name: Company: Address: City: State / Province: Postal code / Zip: Telephone: ( ) Fax: ( ) Signature: Method of Payment: Payment endorsed, check is payable to : progamma Science Corporation Please invoice my company for the amount of $ and our PO# is Please charge my credit card: Please Fax this form or save and if you are paying with credit card Card Type: Card Number: Expiry Date: Name (as shown on card): Signature (required): Authorization # Date: Registration fee: USD includes the presentation material, for the registered delegate for on-line training of 20 hours for a period of 21 days from activation 24/7. This course is for one person at a time. Each candidate will have his own account and password Cancellation / Substitutions: Course registration is personal and system security is assured. All entries are secured and encrypted. A user name and a password is assigned to each user. Course starts only after payment is received. You cannot cancel the course but a delegate can be substituted before the course is activated