Source: http://www.gmpbootcamp.com/2dayDeviceGMPConference-AC-June.htm
Timestamp: 2018-04-19 11:25:28
Document Index: 753155631

Matched Legal Cases: ['art 11', 'art 820', 'art 11', 'art 11', 'art 11', 'art 11', 'art 820', 'art 11', 'art 820']

Device GMP Conference-AC-June
The Auditing Group
tel: (609) 526-3464
3 Day Master GMP
3 Day Device QSR
2 Day Drug GMP
1 Day Drug GMP
1 Day Device GMP
2 Day Device GMP
1 Day Validation
1 Day GMP Labeling
1 Day 21 CFR Part 11
1 Day Laboratory
Boot Camps & Audit
3 Day GMP 2 Day Audit
2 Day GMP 2 Day Audit
2 Day GMP 1 Day Audit
Audit Contracts - Jobs
2 Day Device (ISO 13485 / FDA 21 CFR Part 820 QSR) GMP Conference
cGMP Training from the Auditor's Perspective
20 - 21 June, 2018 - Atlantic City, New Jersey
(Looking for the Drug GMP Conference? - Click Here)
All Boot Camps Includes:
GMP Seminar Binders,
$995.00 USD Per Person
www.sheratonatlanticcity.com
- Breakfast and Opening Introductions
- GMP 101 The Basics
- 21 CFR Part 11 Basic Overview
21 CFR Part 11 Definitions, System Types and Classifications
21 CFR Part 11 Electronic Records; Electronic Signatures – Predicate Rule
Part 11.10 Sections a) - k)
(b) Copies of records
(c) Protection of records
(d) Limiting system access
(e) Audit trails
(f) Operational system checks
(g) Authority checks (h) Device checks
(i) Education, Training, Experience
(j) Policies and Procedures
(k) Systems documentation
Risk Analysis - Determine Which Systems Need to be Validated
Steering Committee and Charters
- 21 CFR Part 820 Device GMPs (With correlations to QSIT and ISO 13485)
GMP Basics 101
Part 11 Overview
Receiving, in-process, and finished device acceptance
Records - General requirements
Records - Device master record
Records - Device history record
Records - Quality system record
Records - Complaint files
- ISO 13485:2016 (with Comparisons with ISO 13485:2003 and 21 CFR Part 820)
Measurement, analysis and improvement General
- Lunch - Warning Letters
- Validation and Qualification
GAMP Overview
Software / System Development Life Cycle (SDLC)
Compiling the Validation Master Plan (VMP)
Project Plan (PP) Development
Design Specifications / Design Qualifications (DQ)
Auditing GxP Computer Systems
Mr. John F. Cuspilich, Sr. Auditor - Sr. Instructor
John is the CEO of The Auditing Group, Inc. (www.auditing.com). John also serves as the Senior Editor at GMP Publications, Inc. and the CEO of The Validation Group.
John has conducted more than 1200 GxP audits, Gap Analysis and remediation projects world-wide, with over 30 years of hands-on technical and management level experience within the Pharmaceutical, Biotechnology, Medical Device, Petrochemical, Validation, and regulated industries.
John has conducted hundreds of speaking engagements, seminars and bootcamp style training seminars world-wide.
Published, cosponsored and audit reviews of thousands of technical and professional papers, journals and books for hundreds of Companies in the regulated industry.
John has assisted hundreds of companies in meeting and exceeding regulatory compliance, pertaining to ‘for-cause’ or ‘due-diligence’ initiatives. Assisting companies to achieve, resolve, remediate and exceed regulated industry requirements, mandates, ‘for-cause’ and ‘due-diligence’ priorities with the technique of promoting GxP standards and practices through interactive hands-on training.
John has extensive knowledge in industry standards; FDA (CDER, CBER, CDRH, CVM, CFSAN), cGMP, GLP, ICH, OECD, GAMP, ISO, OECD, OSHA, HACCP, HIPPA, EPA and GCP regulations and thorough knowledge in the process of implementation of these standards.
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