Boston Professional Events List


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


Date
Dec 07, 2017 - 08:00 AM
Organizer
Seminar
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Hollywood,
Florida,
United States,
ZIP: 33021
Phone:

Ticket Price: Seminar One Registration - $1,295.00 Special Group Discount Register for Four attendees - $ 3885

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

 

Who will Benefit

•    Compliance officers
•    Consultants/service providers
•    Engineering and design control teams
•    Executive management
•    Managers
•    Manufacturing directors and supervisors
•    Procedure writers



Agenda


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 Details


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.


Event Categories
Keywords: Learning




Comments








Events Calendar

SunMonTueWedThuFriSat
26 27 28 29 30 1 2
3 4 5 6 7 8 9
10 11 12 13 14 15 16
17 18 19 20 21 22 23
24 25 26 27 28 29 30
31 1 2 3 4 5 6

Tag Cloud

Newsletters

Subscribe
VIP Life Time Subscription to our Newsletters!
$399.99
$299.99