2017 workshop GMP’s in practice: quality systems, common sense compliance, and application

By: Ginette M. Collazo, Ph.D, President, Ginette M. Collazo, Inc..
Product code: SEM27
Location 1: Washington D.C Mar 22

Description

Course “2017 workshop GMP’s in practice: quality systems, common sense compliance, and application“ has been Pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 1-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

An Interative Workshop Presented BY WCS & Ginette M. Collazo, LLC.

Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion 

Each attendee will receive 1-Day workshop materials ,Certificate, Complimentary Breakfast , Lunch & High Tea/Coffee provided by WCS.

This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).

Design: Content based, experiential (real site specific examples), 483’s evaluation and Warning Letter discussions. Case studies. 

Areas Covered

1.    Management and Supervision Responsibilities
2.    Quality Risk Management
3.    Knowledge Management and Organizational Learning
4.    Quality Management and Quality Systems
5.    Product and Process Monitoring
6.    Discrepancy Observation and Investigation
7.    Complaints
8.    Qualification and Validation
9.    Learning, Training and Performance
10.    Documents, Records and Recordkeeping
11.    Change Management
12.    Corrective Action and Preventive Action (CAPA)
13.    Materials and Packaging Components
14.    Vendors, Third Parties, and Outsourcing
15.    Sampling
16.    Equipment Cleaning
17.    Sanitation
 

Who will Benefit

•    Compliance officers
•    Consultants/service providers
•    Engineering and design control teams
•    Executive management
•    Managers
•    Manufacturing directors and supervisors
•    Procedure writers
•    Pharmaceutical and cGMP auditors
•    QA/QC personnel
•    R&D staff
•    CAPA specialists
•    Training personnel
•    Instructional designers and technologists

Learning Objectives

Recently, the FDA has issued an increasing number of warning letters citing inadequate employee GMP training.

Meanwhile, companies consistently claim their employees are trained and they can prove it by presenting stacks of sign-in sheets from training sessions. This is the training hoax —operators are told in just a few hours about the contents of hundreds of pages of SOPs.

As a result, these reportedly trained professionals can’t possibly have learned the material and have little recollection of procedures or knowledge of how to handle deviations, resulting in defects, recalls and other product problems that cost companies untold billions of dollars.

Unfortunately, GMP trainers are often expected to do just that — create a training course, get everyone’s signature on the training sign-in sheet and hope that people will work differently. For training to be truly effective, organizations must move from a training environment to a learning environment.

Course Outline:

(8:30 AM - 4:30 PM)

Registration Process - (8:30 am till 8:45 am)

1.    Management and Supervision Responsibilities
2.    Quality Risk Management
3.    Knowledge Management and Organizational Learning
4.    Quality Management and Quality Systems
5.    Product and Process Monitoring
6.    Discrepancy Observation and Investigation
7.    Complaints
8.    Qualification and Validation
9.    Learning, Training and Performance
10.    Documents, Records and Recordkeeping
11.    Change Management
12.    Corrective Action and Preventive Action (CAPA)
13.    Materials and Packaging Components
14.    Vendors, Third Parties, and Outsourcing
15.    Sampling
16.    Equipment Cleaning
17.    Sanitation
18.    Facilities and Utility Systems
19.    Warehousing and Storage
20.    Distribution Practices
21.    Maintenance, Repair, and Calibration
22.    Materials Receiving
23.    Equipment
24.    Manufacturing and Packaging
25.    Identity Control
26.    Label Control
27.    Batch Release
28.    In-process Controls
29.    Clothing and Personal Hygiene

 

 

speaker

Ginette M. CollazoPh.D, President, Ginette M. Collazo, Inc.

Dr. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.

Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.

Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.

Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.

22-March-2018 Washington D.C
Seminar One Registration
$ 694



Special Group Discount Register for Four attendees
$ 2099

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

2 Attendees - 5% off

3 to 6 Attendees - 7% off

7 to 10 Attendees - 15% off

10+ Attendees - 20% 0ff

Other Modes of Payment

Want to register by Wire Transfer?
Please call any of our customer support on 844-267-7299 to help you completed the transfer.

Want to register by check or PO?
Please call any of our customer support on 844-267-7299 or drop any email to help you completed the purchase.

Download Registration Form

Yes, I want to attend this Seminar

Click here to Download Registration Form

Hilton Garden Inn Washington DC / U.S. Capitol  1225 First Street, NE, Washington, DC 20002

How to Reach

Testimonials

I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer
 

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.

 

“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals

 

“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.


“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.

 

“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager

 

Media Partners

Top Media Partners and Sponsors World Compliance Seminars WCS


speaker

Morf Media, Inc. is shaping the future of enterprise compliance training for the mobile workforce. For the first time, a digital compliance training system, Morf Learning™, provides one to one training to millions on a smart phone or tablet. Now in pilot with more than 100 major companies in the financial services and life sciences industries, Morf Learning is proving to be cost-effective and engaging. Morf Learning delivers three-minute mini lessons with a personalized Virtual Coach™ developed using the Octalysis framework designed by world-renowned gamification leader, Yu-Kai Chou. 


speaker

Benefits of enrolling for Media Partner

Your company Logo on all the mailings before and after the event.

Get 10% discount to media partner's subscribers.

Publish your Logo and company data on the event website.

Publish your Logo on the conference material distributed during the conference.

Media Partner’s brochure distributed along with conference material


speaker

MEDIA PARTNERS WORK TO DO

Publish Banner on the Media Partner website.

Insertion of the WCS 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

Sponsors

Top Sponsors for WCS - World Compliance Seminars


speaker

If you wish to sponsor our event

Please contact us: 

partner@worldcomplianceseminars.com or speak with one of the account manager + 844 267-7299


speaker

$2,000 - Silver Sponsor Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

1 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees


speaker

$4,000 - Silver Gold Package Includes

Company name and logo on all materials related to events, and prominent location on WCS web site and event media releases 

Listing in monthly Community Leader newsletter sent to over 50,000 users. 

2 Free Pass for the 2 Day Workshop

Sponsors materials will be distributed onsite to all the attendees

15-20 minutes product demo during the live session

Library of Congress, Washington D.C

Though the Library of Congress doesn't own every book ever published, it sure has most of them, with 532 miles of shelves and 115 million items, with 7,000 added each working day.

Washington Monument, Washington D.C

Prominent 555-foot-high classical obelisk where visitors are whisked by elevator to an observation deck for spectacular views of America's capital.

International Spy Museum, Washington D.C

Opened in 2002, the International Spy Museum provides interactive exhibits and contains the most extensive collection of spy artifacts ever displayed.

National Building Museum, Washington D.C

The National Building Museum is located in the heart of downtown Washington, D.C., a short walk from the National Mall, the Verizon Center, and Capitol Hill. The Museum is metro accessible via the

African American Civil War Memorial & Museum, Washington D.C

The African-American Civil War Museum and Memorial was created to tell the story and pay tribute to African-Americans who fought in the Civil War.

Octagon Museum, Washington D.C

The Octagon Museum was built between 1798-1800 by John Tayloe at the suggestion of George Washington. In 1814, the house was offered to President Madison as temporary quarters after the White House

Back to Top