Barry A. Friedman, Ph.D

Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena

Course Description

The Process Validation Guidelines (January 2011) and the EU Annex 15: Qualification and Validation (October 2015) outline the general principles and approaches the two regulatory bodies consider appropriate elements of process validation for the manufacture of human and animal drugs and biological products, including Active Pharmaceutical Ingredients (APIs). These guidances align Process Validation activities with a product lifecycle concept and with existing FDA and EU guidances, including the FDA/International Conference on Harmonization (ICH), Guidance for Industry, Q8 (R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System. The lifecycle concept, new to these Guidances, link product and process development, qualification of the commercial manufacturing process, and maintenance of the process in a state of control during routine commercial production. These guidances also support process improvement and innovation through sound science and risk management. The new Process Validation Guideline/Practice incorporate elements of Process Validation as early as the Research and Development phase, and continues onward through Technology Transfer, into the Phase 1 IND Clinical Trial manufacturing phase, and ultimately into Phase 2 and 3, and then commercial manufacturing.

Each facility, whether producing small or large molecules requires both an overall Site Validation Plan as well as specific validation plans to manage the multiplicity of validations required to confirm the successful manufacture of each of its products.

This FIVE HOUR/DAY, interactive ON-LINE Seminar which provides a conduit to enhance your understanding of the Continued Process Verification, will be reviewed in detail: where does it begin; what is included; and, when does it end.

Common questions asked by the users of Process Validation include;

How does one integrate these two different concepts (Phase 1, 2, and 3 vs. Stages 1, 2, and 3) and where do they merge?

Do they exist independently of each other or do they complement each other to enhance, build and provide a product that neither alone could. Questions that may arise include where are cGMPs initiated?

To what extent must they be used? Since Stage 3 extends through commercial batch manufacturing, what happens to Phase 3?

Does it follow along or with Stage 3? Questions that exist include how one manages special situations to include viral inactivation and removal, impurity clearance, process consistency, process solution stability, endotoxin, bioburden, and other miscellaneous cell culture tests to include DNA and host cell protein.

These questions will be addressed within Stage 2 as presented here and include utilization of Process Validation and Phase 1, 2 and 3, where their Guidances blend and where they remain distinct. In particular, Stage 3.

Important: Please plan to bring a multidisciplinary group from your Company to gain the most from this very important seminar.


Learning Objectives:

Why these FDA Guidance/EU Guidelines for Industry - Process Validation is so important to the pharmaceutical and biotechnology industry.

What FDA segments are included and excluded within the "NEW" Process Validation.

Where does the Process Validation commence.

What are the Three Stages and Where They Apply within the NEW Process Validation.

How Stage 1 integrates with Phase 1.

The Validation approaches that are included within this Guidance document.

The Statutory and Regulatory Requirements for Process Validation.

An Introduction to Phase 1 Guidance for Industry and Its Application within the "NEW" Process Validation.

The Phase 1 Investigational Drug Requirements -- What is and What is NOT Required.

General Considerations for Process Validation - Stage 2 Process Qualification.

Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2.

General Considerations for Process Validation - Stage 3 Continued Process Verification.

A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance.


Agenda

DAY 01(10:00 AM to 16:00 PM)

10.00 AM: Session Start

  • Introduction, Goals and Objectives, Definitions. Process Validation - Its Importance within the Drug Industry
  • Interaction of the Three Stages with Process Validation
  • Validation Approaches, cGMPs in Clinical Supply Manufacture, Special Manufacturing Situations within Phase 1
  • The Requirements of Phase 1 Investigational Drug Requirements
  • Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2

DAY 02(10:00 AM to 16:00 PM)

  • General Considerations for Process Validation – Stage 2 Process Qualifications
  • Special Considerations for Process Validation – Stage 2
  • General Considerations for Process Validation – Stage 3 Continued Process Verification
  • A Review of EU Annex 15 and its Comparison to FDA’s Process Validation Guidance
  • Concurrent Release of Process Performance Qualification (PPQ) Batches
  • Analytical Methodology and Process Validation; Warning Letter examples

Who Will Benefit:

Those who will benefit from this ON-LINE seminar include

  • Product Development
  • Project Management
  • Regulatory Compliance
  • Quality Assurance
  • Quality Control
  • Manufacturing and Facilities professionals who are required to develop and participate in understanding issues surrounding Process Validation.
Faculty Barry A. Friedman

Barry A. Friedman, Ph.D (30+ Year Exp.)

Ph.D. at The Ohio State University

Sarasota, Florida

Barry A. Friedman, PhD, is a Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing Arena. Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology.

Choose a Pricing Option

€1.295

One Dial-in One Attendee - Live + 6 month Access

You get one log-in for the live virtual seminar for one participant & On Demand Recorded Access for 90 days , presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access for 30 days is included .

€3.995

Group-Max. 10 Attendees - Live + 12 month Access

You get Group log-in for the live virtual seminar for 10 participants, presentation materials , Certificate and the opportunity to ask questions by phone and email. On Demand Recorded Access is Included for 90 days for the Group.

€1.895

Recorded Access Group

You'll have 12 month access to group for an archived recording of the entire 2 day virtual seminar including the Q&A period. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately 48 hours after the session

Our Participants Testimonial


The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )

Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.

Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )

Tracey Kessler ( Director of R&D) CEL-SCI Corporation

I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )

Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma

The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )

Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals

About World Compliance Seminars (WCS)

World Compliance Seminars (WCS) is one stop solution for all your pharmaceuticalbiotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIHEMA, as well as numerous European based national regulatory bodies.

These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical ComplianceProcess Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.

The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.

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