Effective and Pragmatic Vendor Qualification Program for cGMP Compliance


Date & Time:
10 Oct - 11 Oct 2019

Location:
Los Angeles, CA, USA

Download:
Seminar Brochure



REGISTRATION OPTIONS

1 Delegate
  • $1,100.00
  • Register for 1 Attendees
  •       
Group of 3 Delegates
  • $4,200.00 $2,970.00
  • Register for 3 Attendees
  •       
Group of 5 Delegates
  • $7,000.00 $4,400.00
  • Register for 5 Attendees
  •       

Vendor qualification program must be customized for the type of products one manufactures, so that the program will be effective, robust, pragmatic, but at the same time, it will meet the applicable regulatory agencies’ requirements and expectation. Such a task is always challenging, and is not easy to achieve if there is no systematic approach to plan, design, implement & to continuously monitor the program.

It should be also recognized that suppliers are based around the globe, and the supply chain is becoming increasingly complex. Hence conducting effective onsite audits of global suppliers and contract facilities for cGMP require additional resources, so establishing risk based and cost effective audit program is also of prime importance.

Why You Should Attend:

This workshop will consist of theoretical and hands-on practical aspects of learning. This will include US FDA and EU regulatory agencies’ current initiatives and expectation on Vendor Qualification Program.

US FDA and other regulatory agencies consider suppliers and contractors as extension of company’s own operation. Hence, oversight and due diligence of vendor activities via Quality agreements and robust onsite audit programs are essential.

This workshop will give examples of setting up such requirements in a customized manner for the type of products such as drugs, biologics, combination products that companies manufacture. This will include pharma company’s vendors to set-up their own vendor qualification program.

Learning Objectives:

  • Changing current business and regulatory environment in the pharmaceutical industry and impact on the vendor qualification program
  • Complexity of supply chain & Communication challenges
  • Regulatory & Quality Challenges & Strategies for meeting such challenges
  • Understanding of vendor qualification, evaluation & communication of potential risks and strategies for mitigating such risks
  • Concepts and principles for a robust, but pragmatic and cost effective vendor qualification program
  • Setting up a science, system and risk based audit program catered for the type of company
  • Performance monitoring and effective communication
  • Life cycle approach to vendor qualification program,
  • Opportunity to work in a small group. hands-on workshop setup to design and develop a customized vendor qualification program. This will be based on the lesson learned during the seminar. A case study exercise will be given to each group. Participants from each group will present their developed program to all attendees. Instructor’s guidance & support will be available throughout this session. Participants will be able to join the applicable small groups such as drugs, biologics, combination products or vendor categories during the hands-on workshop.
  • Oversight of Outsourcing activities
  • Ample opportunities to ask questions from the course instructor during the seminar.

Who Should Attend:

  • Quality Assurance Specialists & Management Staff
  • Compliance Specialists & Management Staff
  • Quality Auditors & Management Staff
  • Buyers & Supply Chain Staff and Management as applicable
  • Project related QC Analysts & Management as applicable
  • Regulatory Affairs Staff & Management
  • Supplier / Contractor / Distributor Representatives as applicable
  • Production & Management Staff
  • R&D & Management Staff
  • Transport company personnel as applicable (QA/Operation)
  • Project Management as applicable

Nada Kuganathan

Nada Kuganathan is a seasoned Quality and Compliance professional with extensive experience, knowledge and proven track record for more than 30 years in the pharmaceutical industry. This experience included branded, generic, contract and consulting business environment in QA, QC, Compliance, Vendor Qualification, Training, and in the global arena. Nada is currently the president & principal consultant of Enkay Consulting Services Inc., CA, USA. In this capacity, Nada has successfully completed several consulting activities with large, medium and start-up pharmaceutical companies related to Quality, Compliance, Vendor Qualification & Supplier Audits, Training and US FDA Inspection Readiness. His work involves a variety of dosage forms of drugs, combination products (both sterile and non-sterile), biologics, and OTC.

Prior to consulting, Nada served as Executive Director, Global Compliance with Actavis (Formerly Watson and now Allergan). During his career in management positions in QA and Compliance areas, he had conducted numerous strategic quality compliance audits in the lead capacity which included numerous supplier/contractor audits such as API, cell banks, excipient, contract manufacturing, laboratories, R&D facilities, and distribution centers for small and large molecule pharmaceutical products around the world. This also included due diligence audits for product and company acquisition. Nada has actively participated in leadership roles in successful strategic vendor qualification projects at a global level.

He was a member of the board of directors & chair of the evening seminar committee of Pharmaceutical Sciences Group of Canada (1999-2001) and also a working group member of the auditor qualification team for Rx 360, an international pharmaceutical supply chain consortium (2011-2012). Nada has delivered numerous presentations to pharmaceutical and API industry professionals on QA, Compliance, Auditing, Validation and Microbiology/Aseptic topics via leading professional organizations such as PDA, ISPE, IVT, CBI, SWE, PSG in the US, Canada, Europe, and India.

DAY 1 : (9 AM – 4.30 PM)

9.00 – 9.30 AM: Introduction & Opening discussion
9.30 – 10.30 AM:

  • Changing business & regulatory environment & Impact on Vendor Qualification Program
  • Quality & Regulatory requirements, Challenges & Potential risk mitigation
  • Key elements of Vendor Qualification Program

10.30 – 10. 45 AM: Break
10.45 – 12.00 PM:

  • Understanding of geographical, business and regulatory landscape of the vendors & complexity of the supply chain
  • Risk based approach to vendor qualification
  • Communication and Contractual & Quality Agreements
  • Existing & Prospective Vendors
  • Database for vendor information. Electronic Vs Manual System, Challenges & Resolution.

12.00 PM – 1.00 PM: Lunch
1.00 – 3.00 PM:

  • Establishing robust, cost effective, but pragmatic vendor qualification program
  • Establish basic principles for a robust program
  • Establish vendor qualification policy under various business models
  • Maintenance of the vendor qualification program, challenges & risk mitigation
  • Communication & partnership with vendors to achieve common goals

3.00 – 3.15 PM: Break
3.15 – 4.30 PM:

  • Oversight of outsourcing activities
  • Approach to Contract manufacturing & Contract testing
  • Handling Contractors, Consultants & Service Providers

DAY 2 : (9 AM – 4 PM)

9.00 – 10.15 AM:

  • Science, Risk, and System based audit program
  • Audit approaches to handle various scenario
  • Strengths, Weakness, Opportunities & Threats (SWOT) of the program
  • Auditor selection & training
  • Audit process

10.15 – 10.30 AM: Break
10.30 – 12.00 PM:

  • Performance Monitoring & Effective Communication
  • Quality Metrics & Trending
  • Life cycle approach to Vendor Qualification
    • Handling regulatory inspection with regard to vendor qualification
  • Pre-Approval Inspection vs Routine GMP Inspection
  • Suppliers’ vendor qualification program

12.00 – 1.00 PM: Lunch
1.00 – 3.15 PM: Hands-on Workshop
3.15 – 3.30 PM: Break
3.30 – 4.00 PM: Question & Answer Session

Los Angeles, CA, USA

PRICING OPTIONS

For Single Delegate – $ 1100 (Save $ 300 on Early Bird Discount)
Regular Price – $ 1400

Get 10% Discount on Group of 3 Delegates – $ 990 / Delegate on Early Bird Offer (Save $ 840)
Get 20% Discount on Group of 5 Delegates – $ 880 / Delegate on Early Bird Offer (Save $ 1800)

EARLY BIRD OFFERS CLOSES ON SEPTEMBER 26, 2019

Early bird seats are limited and based on first-come, first-serve.

For discounts on multiple registrations, contact customer care at +1-416-915-4458

Register


Payment Options

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  • Please bring the respective passes to the event venue.
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    FutureCorp Consulting Inc
    5969, Candlebrook Ct.,
    Mississauga, ON L5V 2V5,
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  • Once we receive the check, you will be receiving a Form to fill up the Delegates Information
  • After payment receipt, from the registered attendee, an electronic event pass (eTicket) will be sent to the email addresses associated with the registered delegates, 5 working days before the seminar date. Please bring the respective passes to the event venue.
Los Angeles, CA
October 10 – 11, 2019
Venue to be announced

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us at +1-416-915-4458 or email us at info@webinarcompliance.com

Payment Policy:

Payment is required to be made at least 2 business days prior to the date of the conference. We accept American Express, Visa and MasterCard.

To make payment by Wire Transfer, kindly call our Customer Support to assist you with completing your registration. Registrations by Wire are required to be made at least 7 business days before the date of the conference. Payments to be made in full.

To make payment through a check, please draw a check to FutureCorp Consulting INC. (our parent company), and kindly call Customer Support to assist you further. Registrations by Check payments are required to be made at least 12 days before the date of the conference. Your check needs to be cleared before your registration is confirmed. A letter of confirmation (along with an electronic event pass) will be e-mailed to you once payment is received. Payments to be made in full. Post-dated checks shall not be accepted.

Customer Support: +1-416-915-4458 Email: info@webinarcompliance.com

Attendance Confirmation and required documents:

After we receive the payment from the registered attendee, an electronic event pass (eTicket) will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the event venue.

Substitution Policy:

If a registered delegate is unable to attend, substitutions can be made at any time at the prevailing rate. However, it has to be confirmed a day prior, in writing with proper identification of the substitute person you plan to send on your behalf. No show will be charged the complete amount.

On-the-spot Registration:

We discourage onsite registrations, however, if you wish to register onsite, payment to happen through credit card immediately at the venue. Conference material will be given on the spot if it is available after distributing to attendees registered in advance. In case it is not available, we will send the material after the conference is over.

Cancellation & Refund Policy:

Written cancellations through email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund – minus a $300 administration fee. No cancellations will be accepted – nor refunds issued – within 10 calendar days before the start date of the event.

On request by email (before the seminar) a credit for the amount paid minus administration fees ($300) could be transferred to any future Compliance Trainings event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

Compliance Trainings reserves the right to change/modify some topics, material or speakers/instructors without notice.

If an event dates and/or venue is changed/cancelled, registrants are required to opt for alternate dates and/or venue provided by Compliance Trainings.

If an event is cancelled altogether, without alternate dates or venue, Compliance Trainings will issue a full refund.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

Compliance Trainings reserves the right to change event/seminar dates, venues or cancel altogether. Registrants will be notified by Compliance Trainings in writing as soon as possible.

Compliance Trainings will not be responsible for travel/accommodation or any other costs incurred due to changes/cancellation.

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