Seminar on Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities at Copenhagen, Denmark

Event Info

Description

Overview:

Companies face many common issues and confusion when creating or revamping their validation programs. Some of these common issues are:

• Company has expertise in its process validation program but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ),
• Customer or 483 audit findings require the company to deviate from its own validation program to meet the needs of the FDA or the customer
• For systems that employ software and hardware, how does the company manage the validation activities (i.e. through the software validation effort or through the equipment qualification program?
  Well, the answers to these and many, many more typical questions are now available in this simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable validation program.

Why should you attend?

Attend this FDA validation seminar to get deep knowledge about:

• How to define a Sustainable Structure of a Firm's Validation Program
• Understand How Change Control and Other Quality Programs Feed Into the Validation Program
• Offer Usable Protocol and Other Validation Program Document Templates
• Define Minimal Recommended Tests and Verifications for
  • Equipment Qualification
  • Process Validation
  • Software Validation
• Common Pitfalls to Avoid When Executing Validation Protocols
• How to Estimate Costs and Time Associated with Validation
• How to Respond to Customer and Regulatory Audit Observations Associated with Validation

Areas Covered in the Session:

• Basics Of Validation
• The Components of a Sustainable Validation Program
• Other Programs that Feed the Validation Program (1 Hour)
• Equipment, Utility, and Facility Qualification
• Process Validation
• Software Validation
• Time and Costs of Validation
• Responding to Validation and Other Related Audit Findings

Who Will Benefit:

• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Validation Managers
• QC Managers
• QA Managers
• Facilities and Engineering Department Staff

Agenda:

Day 1 Schedule:

Lecture 1:

Understanding the Basics of Validation

• Regulatory References
• Validation Terminology

Lecture 2:

The Components of a Sustainable Validation Program

• Design Qualification
• FATs and SATs
• Commissioning
• The Validation Master Plan
• The Validation Project Plan
• Standard Operating Procedures (SOPs)
• Protocols
• Reports
• Additional Software Validation Documents

Lecture 3:

Other Programs that Feed the Validation Program

• Change Control
• Complaint Handling
• CAPAs
• Deviation Management
• Maintenance
• Sales

Lecture 4:

Equipment, Utility, and Facility Qualification

• The SOP
• Protocol Template
• Minimal Testing and Verifications for IOQ
• Minimal Testing and Verifications for PQ
• Facility Qualification
• Execution of Protocols
• Report Generation

Lecture 5:

Process Validation

• The SOP
• Protocol Template
• Minimal Testing and Verifications
• Execution of Protocols
• Report Generation

Lecture 6:

Software Validation

• The SOP
• Protocol Template
• Additional Software Validation Document Templates
• Minimal Testing and Verifications
• Execution of Protocols
• Report Generation

Lecture 7:

Time and Costs Associated with Validation

• Estimating Time Associated with Each "Deliverable"
• Hidden Costs of Validation
• Estimating Costs of Using Validation Consultants
• How to Recoup Costs Associated with Validation for Contract Manufacturers

Lecture 8:

Responding to Audit Findings Associated with Validation

Day 2 Schedule: Lecture 9:

Welcome and Day 1 Reinforcement 

Lecture 10:

Practical Application # 1 -Equipment Qualification 

Lecture 11:

Practical Application # 2 - 483 Responses

Lecture 12:

Closing Comments

Individual/Open Q&A Session

Speaker:

David R. Dills Regulatory Affairs & Compliance Consultant,

David R. Dills Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA's, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.

He has been directly involved with constructing, reviewing, and/or remediating regulatory submissions, including 510(k), PMA, IDE applications, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent for clients, works closely with the key stakeholders and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.

Mr. Dills has a strong background in the interpretation and applicability of FDA regulations, including 21 CFR 210/211, 21 CFR 820, GMP Quality System implementation and compliance requirements, conducts customized GxP training, leads and directs activities for the registration and approval process and working with Agencies in the Pacific Rim, EU and The Americas, including but not limited to FDA, European Medicines Agency-EMA, MHRH, ANVISA, PMDA, TGA, and Health Canada; and defining and executing regulatory compliance, risk mitigation and remediation strategies in response to inspection findings.

Venue: Hilton Copenhagen Airport

Venue Address: Ellehammersvej 20, Copenhagen, 2770

Date: December 10th & 11th, 2015, Time: 9:00 AM to 6:00 PM

Price: $1,695.00 (Seminar for One Delegate - Without Stay)

                                               &

Price: $2,095.00 (Seminar for One Delegate - With Stay)

Register now and save $200. (Early Bird)

Until November 22, Early Bird Price: $1,695.00 from November 23 to December 08, Regular Price: $1,895.00

Until November 22, Early Bird Price: $2,095.00 from November 23 to December 08, Regular Price: $2,295.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: supportglobalcompliancepanel [dot] com     

Website: http://www.globalcompliancepanel.com

Registration Link - http://bit.ly/1QrgUT2

• business & innovation

• FDA Form 483 Audit
• FDA Form 483
• FDA Warning Letters
• FDA Regulation
• FDA Validation
• Regulatory Audit Observations
• Validation Program
• Software Validation
• Standard Operating Procedures (SOPs)

Organiser