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2-day In-person Seminar

Modern Approaches to Process Validation: Requirements for Process Design, Design of Facilities and the Qualification of Equipment and Utilities

December 10th & 11th, 2015

Time: 9:00 AM to 6:00 PM

Copenhagen, Denmark

Venue: Hilton Copenhagen Airport

Director : David R. Dills
  (Without stay)   Price: $1,895.00
(Seminar Fee for One Delegate)

  (With stay)   Includes   Price: $2,295.00
(Seminar Fee for One Delegate)

**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.

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

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 Response

Lecture 12:

Closing Comments

Individual/Open Q&A Session

Seminar Pricing Includes (With stay)
2 Days' Stay
Pick-up and Drop Facility (Nearest Airport)
Breakfast and Lunch
High Tea
Pack of 3 Past Webinars on similar subject
Group participations
Get fabulous discounts by participating in groups of two or more.
No Attendees Discount
1 2 Attendees 10% off
2 3 to 6 Attendees 20% off
3 7 to 10 Attendees 25% off
4 10+ Attendees 30% off

To avail the above group discounts, all the participants should register by making a single payment

Call our representative TODAY on 1800 447 9407 to have your seats confirmed!

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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. Additional activities include Pre-FDA Facility Inspections, Mock Audits/Due diligence and assessing state of readiness for Pre-approval inspection (PAI/PMA), proof of management oversight, facilitate and direct efforts for remediation planning and monitoring, and assessment of the critical sub-systems, records and document controls

He provides PM support and consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process from premarketing to postmarketing; conducting supplier and QS audits/assessments; establishment registration and listing; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting GxP audits and preparing CAP/remediation plans; compliance engineering support; support and/or lead efforts regarding Adverse Event, MDR, Incident Reporting, Postmarketing Surveillance and Vigilance Reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing.

Mr. Dills manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations/commercial opportunities. Develops strategies for governmental approval to introduce new products to market, provides guidance and clarity on regulatory requirements, prepares and/or reviews submissions [e.g., NDA, ANDA, e-CTD, 510(k), PMA, IDE and BLA], including design dossiers and technical files, and other applications for the Pacific Rim, The Americas and EU. Directs and leads efforts in establishing and retooling QA systems with emphasis on preventing the design, manufacture, and shipment of defective products.

Mr. Dills manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, and complaints) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. Background encompasses broad capabilities in quality systems; documentation development and remediation; RA/RC oversight and governance; design controls; CAPA/investigations; GxP training; software and process validation with compliance oversight; supplier management; interfaces with FDA and other Agencies on the regulatory landscape; compliance with MDD/IVDD Directives and Technical File/Design Dossier and CE Mark requirements; and demonstrates credible experience to optimize business performance through proactive strategies to mitigate compliance exposure.

He also develops strategies and adds business value to manufacturers by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones and on minimizing delays due to noncompliance. He conducts Compliance Governance Assessments and Agency Mock Inspections; provides assistance during inspections and with post-inspection correspondence and meetings, involved in the product life cycle and commercialization process and works effectively across all functions for overall corporate compliance to support a company's goals and strategies.

Mr. Dills analyzes the benefits/risks for informed decision-making; interprets the regulatory precedents and new legislation; understands the competitive landscape; develops the business and regulatory approach; conducts persuasive communication with authorities (FDA, PMDA, EMA/MHRA, TGA, MOH, ANVISA, CFDA and other Agencies); executes an effective path to approval; assists with GxP compliance strategies, effectively coordinates development in multiple markets; selects appropriate testing and manufacturing suppliers; and strives for overall corporate compliance with regulations in The Americas, EU, and Pacific Rim.

He provides direction on understanding the regulatory landscape for the product and provides a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.

Mr. Dills has served on the Faculty Advisory Board for the Pharmaceutical Training Institute, Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology and on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore's Who's Who of Professionals.

Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter. Mr. Dills' academic degrees include Environmental Science and Biology. He is a former Chair and Co- Chair of ASQ's Section 1506 and associated with the Biomedical Division, RAPS, AdvaMed, PDA, ISPE, and other industry working groups.

Location: Copenhagen, Denmark

Hotel: Hilton Copenhagen Airport   Ellehammersvej 20, Copenhagen, 2770,     Denmark TEL: +45-32-501-501
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