Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation)

Transcription

1 Global CompliancePanel Knowledge, a Way Forward 2-day In-person Seminar: Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Los Angeles, CA July 28th & 29th, :00 AM to 6:00 PM Price (Without Stay) Price: $1, (Seminar for One Delegate) Register now and save $200. (Early Bird) Barry A Friedman Consultant in Biotechnology, Regulatory Compliance and Aseptic Processing Arena **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. Overview: 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.

2 Global CompliancePanel 2-day In-person Seminar: Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) AGENDA: Day One Day Two Lecture 1: Introduction; Goals and Objectives; Definitions Lecture 2: Process Validation - Its Importance within the Drug Industry Lecture 3: Interaction of the Three Stages with Process Validation Lecture 1: General Considerations for Process Validation - Stage 2 Process Qualification Lecture 2: Special Considerations for Process Validation - Stage 2 Lecture 4: Changes with the Commencement of Process Validation Lecture 3: General Considerations for Process Validation - Stage 3 Continued Process Verification Lecture 5: Validation Approaches Lecture 6: cgmps in Clinical Supply Manufacture Lecture 4: A Review of EU Annex 15 and its Comparison to FDA s Process Validation Guidance Lecture 7: Special Manufacturing Situations within Phase 1 Lecture 8: The Requirements for "Safe" Product within Stage 1 Lecture 5: Concurrent Release of Process performance Qualification (PPQ) Batches Lecture 9: The Requirements of Phase 1 Investigational Drug Requirement Lecture10: Regulatory Strategies for Phase 2 and 3 and their Incorporation within Stages 1 and 2 Lecture 11: Questions? Lecture 6: Analytical Methodology and Process Validation Lecture 7: Warning Letters Related to Process Validation Lecture 8: Questions? Why should you attend: The Process Validation Guidance for Industry was recently revised after many years. With the emphasis today on being able to assure that a process is meeting its requirements through Validation, and not simply through Verification or Qualification, an understanding of both its importance and how to accomplish this feat has come to the fore. In addition, with ICH Q9, Risk Management, involved in every aspect of our day to day operations, it becomes especially important to learn how this meshes with Process Validation. The FDA and especially CDER, with their new auditing format, will be wanting to understand how each Company performed their Validations in all areas to include manufacturing and Quality. Having an enhanced understanding of the Process Validation Guidance will assure that your firm is meeting the FDA s current requirements.

3 Global CompliancePanel 2-day In-person Seminar: Process Validation Guidance Requirements (FDA and EU Annex 15: Qualification and Validation) Group Participation What You will get 10% 2 Attendees to get offer 1 Learning Objectives 20% 3 to 6 Attendees to get offer 2 Participation certificates 25% 7 to 10 Attendees to get offer 3 Interactive sessions with the US expert 30% 10+ Attendees to get offer 4 Post event assistance to your queries. Payment Option 5 Special price on future purchase of web based trainings. 1 2 Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA 6 7 Special price on future consulting or expertise services. Special price on future seminars by GlobalCompliancePanel. 3 PO: Please drop an to [email protected] or call the our toll free for the invoice and 8 Seminar Kit includes presentation handout, ID card, brochure, trainings catalog, notepad you may fax the PO to and pen. 4 Wire Transfer: Please drop an to [email protected] or call our toll free for the wire transfer 9 Networking with industry's top notch professionals information Contact Information: Event Coordinator NetZealous LLC, DBA GlobalComplianePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Toll free: Fax: Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar GlobalCompliancePanel [email protected]