Internal Audits and Supplier Audits for Life Science Companies: 2-day In-Person Seminar

By: John E Lincoln, Principal, J. E. Lincoln and Associates LLC
Coming soon.. Please contact customer care for new schedule
Course “Internal Audits and Supplier Audits for Life Science Companies” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

We need the below information to serve you better

Course Description:

This highly interactive course on auditing will develop / review a company’s internal audit plan and supplier / vendor audit methodology for compliance to the CGMPs. It will address the U.S. FDA’s newer and tougher regulatory stance. Major failings are lack of rigor and/or insufficient knowledge on the part of the auditor.

This internal audit seminar will focus on the following topics:

  • Annual audit coverage for dietary supplements, 21 CFR 111, pharma, 21 CFR 211, devices, 21 CFR 820, and combination products, 21 CFR 4;
  • The internal audit SOP;
  • Conduct of each audit:
    • Audit plan;
    • The team;
    • Initial contacts;
    • The Audit;
    • The initial audit report and discussions;
    • The corrective action plan;
    • The final / formal audit report
  • Supplier / Vendor Audits
    • SOP-defined
    • “Risk-based” per ISO 14971, and/or ICH Q9;
    • Formal supplier rankings;
    • The site audit (preferred):
      • Audit plan;
      • The team;
      • Initial contacts;
      • The Audit;
      • The initial audit report and discussions;
      • The corrective action plan;
      • The final / formal audit report
    • Paper audits:
      • SOP-defined formats;
      • The audit form;
      • Review;
      • Data follow-ups and documentation;
      • The corrective action plan;
      • The final / formal audit follow-up report

Key points will be further emphasized by supervised breakout group projects, presentations and critiques.

Learning Objectives:

Upon completing this course participants will understand:

  • Importance and key components of internal and supplier / vendor cGMP compliance audits;
  • Supplier rankings based on Product / RM / Component / Service Risk ;
  • Internal audit SOP and monthly audits; 483 inclusions;
  • Supplier audit questionnaire / templates;
  • Compile “generic” supplier ranking matrices;
  • Audit plan;
  • Audit team;
  • Conduct of the internal audit;
  • Conduct of the supplier audit;
  • Supplier COAs and COCs;
  • Interim and final reports;
  • Action plans and CAPA;
  • Required controlled documentation and how to present;
  • Compile “generic” audit SOPs;
  • Importance of “Entropy”

Who will Benefit:

This seminar will provide valuable assistance to all regulated companies that need to review and modify their internal audit and vendor / supplier audit programs. This information is addressed to regulated industries in medical devices, pharmaceutical, diagnostic, biologics, and combination products. The employees who will benefit include:

  • Senior and middle management and staff
  • Regulatory Affairs
  • QA/QC
  • IT/IS
  • R&D
  • Production Management
  • Manufacturing Engineers
  • Process Engineers
  • Software Engineers

Course Outline:

Day One (8:30 AM – 5:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM


09:00 - Introductions; Housekeeping Announcements; Workbook Walk-Through

09:30 - Internal CGMP Compliance Audits – Plan, Conduct, Interim and Final Report / Action Plan -- Slides

10:30 - Break and Q & A

11:00 - Internal Audits – Slides Continued; Q&A

12:00 - The U.S. FDA CGMP-Compliance Audit “Model”; Internal Audit SOP; Audit Teams; Training

12:30 - Lunch

01:30 - Key Internal Audit Elements; “Entropy” and How to Address Group project— Develop a 1) Pharma-based and a 2) Device-based “generic” Audit SOP

03:00 - Break

03:30 - Group Presentations and Discussion of Project Results

04:00 - Review of Internal CGMP Audits, Cover “Letters” / Proof of Compliance, Importance to FDA

04:30 - Internal Audits Q&A

05:00 - Day One Wrap-up

Day Two (8:30 AM – 4:30 PM)

08:30 - Address any Day One Questions / Issues

09:00 - Develop and Employ a Compliant Vendor / Supplier / Contractor Audit Program – Template, Audit Plan, Approaches, Final Report / Action Plan -- Slides

10:00 - Break and Q & A

10:30 - Vendor Audits – Slides Continued; Q&A

11:30 - Product “Risk-Based Supplier Rankings, based on ISO 14971

12:00 - Lunch

01:00 - Audit Alternatives: On-Site, Written, Or…; COAs and COCs

    Group Projects:
  1. Develop a Product “Risk-Based” Product Ranking Matrix for Devices;
  2. Develop the same for Drugs; Define how each rank of the matrix would be audited

02:30 - Break and Q & A

03:00 - Group Presentations and Discussion of Project Results

03:30 - Review of Supplier Audits; Q&A

04:00 - Review of Internal Audits and Related Subjects; Required Documentation; Q&A

04:30 - Course Wrap Up

Meet Your Instructor

john_lincoln_large
John E Lincoln
Principal, J. E. Lincoln and Associates LLC

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

In addition, he has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He is a graduate of UCLA.

Register Online

Register Online

$0
Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-1-888-771-6965 or email at editor@grcseminars.com

Group Registrations

Send Your Team for Maximum Benefit Get your team up to speed!

Significant tuition discounts are available for teams of two or more from the same company. You must register at the same time and provide a single payment to take advantage of the discount.

  • 2 Attendees
  • 3 to 6 Attendees
  • 7 to 10 Attendees
  • 10+ Attendees
  • -
  • -
  • -
  • -
  • Get 10% off
  • Get 20% off
  • Get 25% off
  • Get 30% off
Call Toll Free +1-1-888-771-6965 if you have any queries.

Register by Wire Transfer

If you wish to pay by wire transfer: Please call us at
Toll Free +1-1-888-771-6965


Download Registration Form

Yes, I want to attend "Internal Audits and Supplier Audits for Life Science Companies: 2-day In-Person Seminar"
Click here to Download Registration Form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company). and mailed to:
2600 E. Bayshore Road
Palo Alto, CA 94303
USA

Terms & Conditions to register for the Seminar/Conference/Event

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 @ +1-888-771-6965 or email us @ editor@grcseminars.com

Payment:

Payment is required before 2 days of the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. ( our parent company)

Cancellations and Substitutions:

Written cancellations through fax or 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 — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days from the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future GRC Seminars event and a credit note will be issued.

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

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

In the event GRC Seminars cancels the seminar, GRC Seminars is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and Documents to carry to the seminar venue:

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

Conference photograph / video:

By registering and attending GRC Seminars conference you agree to have your photographs or videos taken at the conference venue and you do not have any objections to use these photos and videos by GRC Seminars for marketing, archiving or any other conference related activities. You agree to release GRC Seminars for any kind of claims arising out of copyright or privacy violations.

Media Partners

If you wish to partner with us for this event please contact us: partner@grcseminars.com or call us: +1-888-771-6965.
Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media Partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.
Media Partner to do
  • Banner (min 728x90 or 468x60) on the Media Partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the Magazine and/or Website.
  • Dedicated email blast to all subscribers of Media Partner.
  • Article on the Magazine and/or Website after the conference.

Sponsors

If you wish to sponsor this event please contact Ben Hobbs: benhobbs@grcseminars.com or call us: (650) 620-2941

Local Attractions:

Hoover Dam Supercar Tour
Drive four exotic cars on a thrilling round-trip guided road tour between the Las Vegas Strip and the Hoover Dam. During this supercar driving experience, you’ll get behind the wheel of four supercars. You'll discover for yourself what makes each so special.

Walking Gourmet Food Tours
Walking Gourmet Food Tours is a food tasting exploration of the many eclectic tastes of Las Vegas. Enjoy the highest quality food and drink at venues you might not have found on your own. From tasty appetizers and world-renowned entrees to signature cocktails and mouthwatering desserts, your taste buds will be tingling the entire time.


Vegas Indoor Skydiving
This is America’s first indoor skydiving built in 1982. Vegas Indoor Skydiving simulates the free fall aspect of skydiving without the use of an airplane or parachute. The experience is similar to skydiving with the addition of a mesh trampoline floor and foam padded walls.


National Atomic Testing Museum
The 10,000 square foot Atomic Testing Museum is one of the most popular museums in Las Vegas that is run by the Nevada Test Site Historical Foundation, and affiliated with the Smithsonian Institute. This museum is packed full of exhibits, movies, artifacts, and memorabilia relating to Nevada’s contributions to atomic energy research as well as providing a historical view of nuclear fusion and its impact on world politics.
Shark Reef Aquarium
Completed at a cost of nearly $60 million, the fully themed facility was designed with the idea of immersing the visitor into this underwater world in the desert. View a diverse cross-section of magnificent aquatic creatures, including 100 sharks, (15 species in all) along with exotic fish, reptiles and sea turtles.

The Mob Museum
The Mob Museum Las Vegas transforms one of the area’s most historic buildings and brings to life a fascinating chapter in the history of both the US and the city itself. It is an interactive Museum dedicated to the history of organized crime and law enforcement. The Museum presents a bold and authentic view of organized crime’s impact on Las Vegas history, as well as, its unique imprint on America and the world. If you are looking for something unique and off the strip in Las Vegas, the Mob Museum is it!


Freemont Street Experience
Located in Downtown Las Vegas, the Fremont Street Experience offers free nightly shows featuring 12.5 million lights and 550,000 watts of amazing sound at VivaVision. Enjoy free concerts and special events throughout the year. The world-famous, one-of-a-kind entertainment venue is home to Viva Vision, the biggest big screen on the planet. Ten legendary casinos line Fremont Street Experience with more than 60 restaurants and thousands of loose slots.