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Validation Master Planning and Regulatory
Expectations
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile:
• Louis Angelucci is a pharmaceutical
professional and Certified Quality
Engineer with over 20 years of
experience in Quality Assurance, Quality
Control, Validation, consent decree
remediation as well as cGMP
Compliance in the Medical Device and
Pharmaceutical industries. Lou has
worked for several well known
companies inclusive of Johnson &
Johnson, Bristol-Meyer Squibb, Pfizer,
Schering Plough and Merck.
Louis A. Angelucc
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description:
This webinar will provide all pharmaceutical and
medical device companies with an approach to the
expectations associated with a validation master
plan (VMP) for product/equipment transfer,
facilities, as well as develop a company standard.
It will also provide a detailed insight on the best
practices for developing and implementing a good
plan regarding responsibilities and deliverables to
make validation efficient and consistent along with
regulatory expectations.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives of the Presentation:
• What is a VMP (Validation Master
Planning) and how is it valuable to my
company?
• What topics are covered in the VMP and
to what extent?
• How is the VMP controlled and updated?
• How is the VMP implemented?
• Who contributes to the VMP?
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Areas Covered:
• History and background
• Types
• Organization
• Requirements
• Regulatory expectations
• Maintenance
• Use
• Upkeep
• PICs guideline
• 2011 requirements
• Do's and don'ts
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit:
• Quality Assurance Personnel
• Regulatory Affairs Professionals
• Operations Staff Engineers
• Quality Engineers
• Compliance Personnel
• QA Personnel
• validation Personnel
• Engineering including software
• All personnel involved in verification and/or
validation planning, execution and
documentationwww.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Track this Link:
Validation Master Planning and
Regulatory Expectations
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
www.onlinecompliancepanel.com

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Validation Master Planning and Regulatory Expectations

  • 1. Validation Master Planning and Regulatory Expectations www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 2. Instructor Profile: • Louis Angelucci is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation as well as cGMP Compliance in the Medical Device and Pharmaceutical industries. Lou has worked for several well known companies inclusive of Johnson & Johnson, Bristol-Meyer Squibb, Pfizer, Schering Plough and Merck. Louis A. Angelucc www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 3. Description: This webinar will provide all pharmaceutical and medical device companies with an approach to the expectations associated with a validation master plan (VMP) for product/equipment transfer, facilities, as well as develop a company standard. It will also provide a detailed insight on the best practices for developing and implementing a good plan regarding responsibilities and deliverables to make validation efficient and consistent along with regulatory expectations. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 4. Objectives of the Presentation: • What is a VMP (Validation Master Planning) and how is it valuable to my company? • What topics are covered in the VMP and to what extent? • How is the VMP controlled and updated? • How is the VMP implemented? • Who contributes to the VMP? www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 5. Areas Covered: • History and background • Types • Organization • Requirements • Regulatory expectations • Maintenance • Use • Upkeep • PICs guideline • 2011 requirements • Do's and don'ts www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 6. Who can Benefit: • Quality Assurance Personnel • Regulatory Affairs Professionals • Operations Staff Engineers • Quality Engineers • Compliance Personnel • QA Personnel • validation Personnel • Engineering including software • All personnel involved in verification and/or validation planning, execution and documentationwww.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
  • 7. Track this Link: Validation Master Planning and Regulatory Expectations www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com www.onlinecompliancepanel.com