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Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here.

On-line Audio Seminar 140

Developing a Validation Master Plan for Pharmaceutical Manufacturing

Includes an Example Master Plan and SOPs

Gabriela Bodea

Recorded

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A Validation Master Plan (VMP) ensures an organized approach of facility validation, either a new
premise or upgrade of an existing one. That is beneficial for the business, preventing undesirable delays and costs. In addition, a VMP facilitates the understanding of a company’s validation philosophy and policy and ensures consistent and effective validation.

Key Questions related to Validation Master Plans are:

  • Is a VMP a required by US and International FDA's?
  • What exactly is a VMP
  • When to develop a VMP?
  • What should be the contents of a VMP?
  • Who should write and review a VMP?
  • What documentation should be used in conjunction with VMP?
  • What are the support programs relevant for a VMP?
  • Should Risk Assessment be included in the VMP?
  • Which tools are available to manage and document planning?
  • How to make sure that the plan is properly executed in time?

How does the audio seminar help:

Answers will be presented by Gabriela Bodea in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations. After the seminar, an extensive list of reference material like an Example Master Plan SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Regulatory requirements
  • VMP as a controlled document
  • Benefits of a VMP
  • Defining a VMP
  • Situations that require a VMP
  • Key contents of a VMP
    - intro, purpose, scope, responsibilities
    - Validation requirements and approach
    - Qualification approach: commissioning & qualification,
    documentation required by VMP (URS, FAT, SAT)
  • VMP development, approval, distribution, review of progress, and update
  • Good practices to streamline validation

And for easy and instant implementation:
Get 10+ documents through special seminar website

  • SOP: Installation Qualification for Manufacturing Equipment
  • SOP: Operational Qualification for Manufacturing Equipment
    Comprehensive VMP Example for an Oral Solid Dosage Forms Manufacturing Plant
  • SOP: Risk Assessment for GxP Systems
  • SOP: Qualification of Equipment
  • Example: Performance Qualification - HVAC Systems - White Product Lines
  • Qualification & Validation Matrix
  • Links
    Guidance for Industry: Annex 15 to the EU Guide to Good Manufacturing Practice - Qualification and validation, Brussels 2001
    - Link to PIC/S - Recommendation on Validation Master Plan Installation and Operational Qualification: Non-Sterile Process Validation Cleaning Validation, July 2004
    - Health Science Authority (HSA), a member of PIC/S - GUIDE-MQA-005-005: Guidance Notes on Preparation of Validation Master Plan, Sept 2004
  • Related literature
    - Questions & Answers on the Australian Code of GMP for Medicinal Products, 16 August 2002
    - Facility Validation: A Case Study for Integrating and Streamlining the Validation Approach to Reduce Project Resources, By Graham C. Wrigley Pfizer Global Manufacturing an Jan L. du Preez, Ph.D. Research Institute for Industrial Pharmacy
  • Presentation from FDA's John Dietrick, a compliance officer in the Center's Division of Manufacturing on FDA's concepts for Process Validation. "Without a Validation Master Plan, there may be no direction and little likelihood of success" Mr. Dietrick said. "It is a tool for planning and documentation and is required by EU as spelled out in Annex 15 of the EU (EC) GMP directive".

Who should attend?

  • Manufacturing managers and personnel
  • QC/QA managers and personnel
  • RA staff involved in auditing validation protocols and reports
  • Personnel in the Pharmaceutical Manufacturing engaged in validation activities
  • Senior Management who need to allocate validation resources & review & approve validation
  • Program
  • Validation specialists from Manufacturing, Quality and Engineering/Maintenance
  • Departments
  • Documentation department
  • Consultants

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.