Comparing The Product Lifecycle of Drugs, Devices & Combination Products

Join Us to Enhance Your Understanding of Relationships Between Functions Efficiency and Cost, including Product & Company Value.

Instructor :
Howard Cooper

Webinar ID:
2962

Date: 13 May 22

Start Time: 11 am PT

Duration: 2 Hrs

What you will learn

  • 21 CFR Parts 210 & 211 & Part 820
  • ISO 13485:2016 (References to this document)
  • FDA Guidance documents
  • ICH Q7A, GMP for Active Pharmaceutical Ingredients
  • Q8, Q9 and Q10
  • 21 CFR Parts 210 & 211 & Part 820
  • ISO 13485:2016 (References to this document)
  • FDA Guidance documents
  • ICH Q7A, GMP for Active Pharmaceutical Ingredients
  • Q8-Pharmaceutical Development losses management.
  • Life is a bit of why Q9-quality risk management.
  • Q10-while being able to pharmaceutical quality system forces are trying to R4

Course Description

We discuss the following:

  • Importance of understanding the product and its environment
  • How does product diagnostic and treatment cycle impact the assessment of your product and its value throughout the product lifecycle.
  • Management must plan and select competent personnel and participate in planning all the related activities.
  • The pharmaceutical product lifecycle begins at R&D turnover of product concepts and technology and at which time a quasi-Master Record is prepared for planning.
  • Priority must be given to obtaining official FDA designation and classification as a drug, medical device, or combination product. Then, begin planning for regulatory filings and meetings.
  • Begin GLP laboratory qualification ending with qualification & GLP Protocol and approval.
  • Allocate resources for testing activities or begin qualifying a contract laboratory.
  • Using the Master Record, manufacture the GLP batch and test characterizing regarding appropriate GLP requirements. If it is a drug-device combination, determine the GLP biocompatibility needs and requirements.
  • Final GLP Lab qualification -Begin GLP studies-Follow-up.
  • GLP Data Analysis-Phase 1 Planning
  • IND submission-manufacture planning according to ICH-7A (Investigational Product Section)
  • Decision—Use GLP batch or manufacture a new batch
  • ImportantYou & Your company must realize that the regulations are only minimum requirements. You must know industry practices and, most importantly, study the works of quality gurus whose works are the basis for many regulations.
    1-Human Safety-Start Phase 2 manufacturing & testing.
  • Phase 2-Human Efficacy-Continuing Technical development &implementation, IQ & OQ–Start labeling & advertising controls and continue throughout PLC
  • Phase 3-Increased patient inclusion, Start…

We discuss the following:

  • Importance of understanding the product and its environment
  • How does product diagnostic and treatment cycle impact the assessment of your product and its value throughout the product lifecycle.
  • Management must plan and select competent personnel and participate in planning all the related activities.
  • The pharmaceutical product lifecycle begins at R&D turnover of product concepts and technology and at which time a quasi-Master Record is prepared for planning.
  • Priority must be given to obtaining official FDA designation and classification as a drug, medical device, or combination product. Then, begin planning for regulatory filings and meetings.
  • Begin GLP laboratory qualification ending with qualification & GLP Protocol and approval.
  • Allocate resources for testing activities or begin qualifying a contract laboratory.
  • Using the Master Record, manufacture the GLP batch and test characterizing regarding appropriate GLP requirements. If it is a drug-device combination, determine the GLP biocompatibility needs and requirements.
  • Final GLP Lab qualification -Begin GLP studies-Follow-up.
  • GLP Data Analysis-Phase 1 Planning
  • IND submission-manufacture planning according to ICH-7A (Investigational Product Section)
  • Decision—Use GLP batch or manufacture a new batch
  • ImportantYou & Your company must realize that the regulations are only minimum requirements. You must know industry practices and, most importantly, study the works of quality gurus whose works are the basis for many regulations.
    1-Human Safety-Start Phase 2 manufacturing & testing.
  • Phase 2-Human Efficacy-Continuing Technical development &implementation, IQ & OQ–Start labeling & advertising controls and continue throughout PLC
  • Phase 3-Increased patient inclusion, Start NDA, & Validations, File NDA -Pre-Approval Inspection-Plan for continuous analysis of Technical, Safety, & Efficacy.
  • Product Launch& Intensive Monitoring
  • Product & Process Improvement, COQ, Complaints, Failures & Changes

Why you should attend

  • By understanding the intricacies of the product lifecycle and associated cycles, you will better understand your role and the other functional roles.
  • A better understanding of cycles enhances planning. Provide insight to increase the probability of seeing opportunities for improvement and breakthroughs.
  • Gain insights into automation and artificial intelligence potential opportunities. Increase your value to the organization
  • Increase your understanding of relationships between functions efficiency and cost, including PRODUCT & COMPANY VALUE.
  • Enhance and improve the quality manual and establish and improve policies.
  • By understanding the intricacies of the product lifecycle and associated cycles, you will better understand your role and the other functional roles.
  • A better understanding of cycles enhances planning. Provide insight to increase the probability of seeing opportunities for improvement and breakthroughs.
  • Gain insights into automation and artificial intelligence potential opportunities. Increase your value to the organization
  • Increase your understanding of relationships between functions efficiency and cost, including PRODUCT & COMPANY VALUE.
  • Enhance and improve the quality manual and establish and improve policies.

Areas Covered

  • 21 CFR Parts 210 & 211 & Part 820
  • ISO 13485:2016 (References to this document)
  • FDA Guidance documents
  • ICH Q7A, GMP for Active Pharmaceutical Ingredients
  • Q8-Pharmaceutical Development losses management.
  • Life is a bit of why Q9-quality risk management.
  • Q10-while being able to pharmaceutical quality system forces are trying to R4
  • ICH Q12 TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT
  • IMDRF (International Medical Device Regulators Forum)-Device considerations
  • 21 CFR Parts 210 & 211 & Part 820
  • ISO 13485:2016 (References to this document)
  • FDA Guidance documents
  • ICH Q7A, GMP for Active Pharmaceutical Ingredients
  • Q8-Pharmaceutical Development losses management.
  • Life is a bit of why Q9-quality risk management.
  • Q10-while being able to pharmaceutical quality system forces are trying to R4
  • ICH Q12 TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT
  • IMDRF (International Medical Device Regulators Forum)-Device considerations

Who is this course for

  • Senior Management (To participate to demonstrate support & lead and gain insight to utilize resources better to meet company objectives)
  • Cost Accounting (to better understand the impact of increasing activity, add complexity to both (direct & Indirect Costs, and better apply Cost of Quality Concepts
  • Quality (Gain insight for seeing material, process, and product improvements)
  • Sales & Marketing (Communicate with customers on complaints and product requirements)
  • Engineering (Key players in the design and be more aware of how design impacts the upstream process)
  • Senior Management (To participate to demonstrate support & lead and gain insight to utilize resources better to meet company objectives)
  • Cost Accounting (to better understand the impact of increasing activity, add complexity to both (direct & Indirect Costs, and better apply Cost of Quality Concepts
  • Quality (Gain insight for seeing material, process, and product improvements)
  • Sales & Marketing (Communicate with customers on complaints and product requirements)
  • Engineering (Key players in the design and be more aware of how design impacts the upstream process)

Instructor Profile

Howard Cooper was Introduced to Quality Assurance early in his career at Anheuser-Busch (AB) in a Quality Management Training Program (QMTP) led by Top Management developed to propel the company forward through several years of rapid growth in a highly competitive environment. His 40 years of Experience includes...

Howard Cooper was Introduced to Quality Assurance early in his career at Anheuser-Busch (AB) in a Quality Management Training Program (QMTP) led by Top Management developed to propel the company forward through several years of rapid growth in a highly competitive environment. His 40 years of Experience includes:

  • Drugs, Devices, Biologicals, Combination Products
  • Start-ups from Scratch, Start-Ups, Expansions
  • Auditing & Quality Improvement
  • Revamped failing facilities & Directed Warning Letter & Consent Decree remediation
  • Certified Quality Manager
  • Certified Quality Auditor
  • Certified Biomedical Auditor
  • BS Biology-Chem & BS Political Science
  • MBA-(Need 2 courses)

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