CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar
Howard Cooper, President, EQACT, INC.
San Francisco, CA
| Thursday, November 10, 2016 | Friday, November 11, 2016
This two-day course is designed for those who work in a Current Good Manufacturing Practices (CGMP) environment and whose roles and responsibilities require they understand and apply quality principles inherent in in the regulations they must master and enforce.
This course begins by studying important concepts about the role and scope of quality and compliance and the resulting activities as quality and compliance work in multi-functional teams to achieve product safety and efficacy. Then, the GMP systems/elements (i.e. Facilities & Equipment, Personnel, CAPA, etc.) will be identified and categorized. Each category will be compared to each of GMPs to identify and study the similarities and differences providing insight concerning the function of their own GMP system.
Pharmaceutical and device lifecycles will be presented in order to learn not only the lifecycle but also the quality function role from product concept to commercialization and the end of product life.
||International Guidance DOCS
||FDA Guidance Documents & Publications (Example)
||Relationship To FDA Approval Process
||International Conference on harmonization (ICH)
ICH Q8-ICH Q11)
||2006 FDA publication, The Quality Systems Approach to the Pharmaceutical CGMPS.
||International Medical Device Regulatory Forum (IMDRF-formerly GHTF)
||Inspection of Medical Device Manufacturers (PDF - 707KB)
Design Control Guidance for Medical Device Manufacturers
||Dependent on the product combination
||Current Good Manufacturing Practice Requirements for Combination Products
This course is designed for personnel with all levels of cGMP experience. It will provide cGMP knowledge so they may advance and be prepared for additional responsibilities. Upon completion of this course, attendees will:
- Be able to understand and apply GMP concepts to decision making in a managerial role
- For the beginner, the course provides guidance on how cGMPs apply to their role and responsibilities and how to apply these principles in their daily activities
- For the intermediate & advanced, they will be able to apply what they have learned to better manage quality, solve problems, and make improvements
- To learn about ICH and IMDRF(GHTF) and harmonization documents and gain the perspective of how they may be applied to achieve compliance and improve products and processes to achieve greater customer satisfaction.
- Know the similarities and differences between the FDA's GMP Quality Systems for Active Pharmaceutical Ingredients (Q7A), Drug Product (Part 210/211), Biologicals (Part 600-680) and Medical Devices (Part 820 & ISO 13485)
- Learn the relationships of all the CGMPs to other FDA regulations and to the medical products life cycles
- Have working knowledge of international cGMP regulations
- Know the current compliance “hot spots” that FDA and international authorities look for when inspecting for CGMP compliance
- Know how to better locate regulatory information and to interpret, assess, and make decisions concerning GMP issues
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
Who will Benefit:
As previously stated, this course is designed for all levels of quality, regulatory, and technical experience. It is also well-suited for many of the typical environments and medical products industry.
- It is ideal for the development, manufacturing, testing, and marketing of combination products because it presents an overall picture of the GMP’s required for combination products.
- For the virtual company, the course provides a guided tour of the product lifecycle and how the requirements for quality and compliance change from development to commercialization and onto post-approval.
- For contractors providing outsourcing to the medical industry, it provides guidance on fulfilling the client’s needs to meet compliance requirements.
- Suppliers to the industry will gain insight and knowledge that will assist them in meeting their clients’ needs for consistent high quality components.
Examples of positions that has the potential benefit include:
- Senior quality managers
- Quality professionals
- Regulatory professionals
- Compliance professionals
- Production supervisors
- Manufacturing engineers
- Production engineers
- Design engineers
- Process owners
- Quality engineers
- Quality auditors
- Document control specialists
|Day One (8:30 AM – 4:30 PM)
||Day Two (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
- Quality & Regulatory Processes
The GMP Foundation: Management, People, and Documentation
- The Food Drug and Cosmetic Act (FDCA)
- The FDA regulatory environment
- From law to regulation-importance of the preamble
- The medical products lifecycle from discovery to post-approval
- The product environment-similarities and differences between medical products
- Regulatory definitions and terms with particular emphasis on Adulteration & Misbranding
- How the regulations define quality?
- Quality vs. Compliance
- The changing GMP paradigm-The Quality Systems Approach & ICH Q10
Design & Risk
- Organizing for Quality
- The Documentation Management Process- “The GMP Constitution”
Facilities & Equipment “A Facility Does Not Make a Company”
- What is design and where does it began and end?
- Quality System Regulation-Design Control
- Q8-Pharmaceutical Development- “Quality by Design (QbD) and Design Space
- Q9-Quality Risk Management
- Design’s impact on the product lifecycle
Materials Control: “Anything that touches the process must be controlled”
- Design of Facilities and Equipment
- Lighting, Plumbing, & Containment/Contamination
- HVAC & Environmental Controls
- Equipment and Facility Qualification
- Equipment Cleaning and Maintenance
- Automated Equipment
- Cleaning Validation
- Utilities & Water Systems
Process Control: “Master Records - The Key to Process Control”
- Classification of materials according to function and Criticality-Labels, Containers, & Materials
- Preparing material specifications
- Auditing, qualifying, and controlling suppliers and contractors
- Material Qualification
- Control of incoming materials
- What do the regulations require for reduced testing?
- The role of the Master Record
- Content and requirements for Master Records of all medical products
- Review and Approval of Master Records
- Converting the Master Record to a Batch or History Record
- Controlling Master Record and Batch/History Records
- Another new Paradigm-Process Analytical Technology (PAT)
- Process Validation
- Principles of Technology Transfer
- Packaging and Labeling Controls: “Identify and Protect the Product”
- Why is packaging and labeling is so important?
- Controlling Printed Materials
- Controlling the design and manufacture of Packaging & Labeling Materials
- Examining and storing Packaging & Labeling Materials
- Controlling labeling operations
Product Release to Distribution & Returned Product
- Barr Decision-An important Milestone in Regulation
- Analytical Methods-Scientific Basis, Approval, & Validation
- Controlling Reagents & Reference Standards
- Laboratory Data-Notebooks, LIMS, & Disks
- Equipment Controls
- Using a Contract Laboratory
- QA Responsibilities in Product Release
- Why perform testing on finished products?
- Batch Record Review-By Operations
- QA Batch Record Review
- Close deviations and non-conformances
Maintaining and Improving Systems
- What Are Deviations and Non-conformances- Why Do They Happen
- Complaints show quality system weaknesses
- Adverse Event Reporting
- The Investigative Team
- Performing investigations to discover root cause
- CAPA Systems-Shared Responsibilities between Quality, Operations, and Senior Management
- Statistical Process Control
- Value-Added Internal Auditing can lead to problem discovery and improvement
- Quality Metrics-$$$- will be heard
- Annual Reporting
- Reporting problems to Senior Management
- Quality Tools
- Pre-approval Inspections (PAI) or Prepare, Anticipate, & Implement
- Detailed discussion of participant questions, problems, and issues
- Top CGMP problems FDA sees at companies
- Discussion of Hot Topics
- Consent Decree Case Studies
- Questions & Answers
- Quiz with Discussion of Answers
Meet Your Instructor
President, EQACT, INC.
Howard Cooper is an independent quality and regulatory consultant with more than 40 years of hands-on, tactical, and strategic experience designing, implementing, managing, and remediating device, pharmaceutical, and biological quality systems. His technical background helps him understand and apply the technology, his political science helps him understand the regulatory process, and his work on an MBA provides a business perspective. He is a Certified Biomedical Auditor (CBA), Certified Quality Manager (CQM), and Certified Quality Auditor (CQA).
After teaching high school science, Howard joined Anheuser-Busch as a Management Quality Trainee to begin his FDA experience. His ability to quickly learn and apply quality principles resulted in promotions to quality supervision and management. He transferred this experience to a medical device contractor about the time FDA medical device regulations were on the horizon. He applied his comprehensive quality experience to revamp both quality and operations to meet all regulations the ride for the medical device amendments.
As a change agent, he enjoys challenging and persuading others to think outside the box to view quality as a positive and energetic force that can make the difference between business success and failure. He emphatically emphasizes the importance of competent and confident people who develop strong working relationships as they work to constantly improve the organization.
Since becoming a consultant in 2004, he has focused on startup and problematic operations using his “change agent mentality”. During presentations, he frequently relates these experiences to illustrate how he mitigated and resolved
Howard particularly enjoys and encourages class participation and discussion during the presentation.
Register by P.O. / Check
Yes, I want to attend "CGMP Quality Principles for the FDA Regulated Industries: 2-Day In-Person Seminar".
Click here to download P.O. form
If you are paying by check:
Checks should be payable to MetricStream Inc. (our parent company) and mailed to:
2479 East Bayshore Road
Palo Alto, CA 94303
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.
||Get 10% off
|3 to 6 Attendees
||Get 20% off
|7 to 10 Attendees
||Get 25% off
||Get 30% off
Call toll free on +1-888-717-2436 if you have any queries.
Register by Wire Transfer
If you wish to pay by wire transfer, please call us toll free on +1-888-717-2436
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 @ +1-888-717-2436 or email us @ firstname.lastname@example.org
Payment is required 2 days before 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 $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 or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline 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 ComplianceOnline cancels the seminar, ComplianceOnline 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 5 working days before the seminar date. Please bring the pass to the venue of the event.
Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.
San Francisco, CA (Venue to be announced shortly)
November 10-11, 2016
If you wish to partner with us for this event
contact us: email@example.com
call us: +1-888-717-2436.
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.
If you wish to sponsor this event
contact Cruise Webster: firstname.lastname@example.org
call us: (207) 576-4173
Think Escape Party Bus
San Francisco Bay Area
Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Planning the perfect night on the town is easy with Think Escape's fleet of luxury buses and extended vehicles, each with different amenities for socializing and transport. Think Escape's Bay Area party bus rentals include free entry into selected exclusive nightclubs, professional hostess and chauffer, in-vehicle coolers stocked with amenities for a perfect night of partying.
Alcatraz Lunch Cruise
The Alcatraz Lunch Cruise is a luxurious way to get to see some of San Francisco’s favorite sights. A gourmet lunch buffet features options like asiago Caesar salad, bay shrimp salad, roasted chicken, garlic-herb roasted new potatoes and more. While guests enjoy lunch, they can take in views of San Francisco Bay’s flora and fauna, Angel Island and Alcatraz, and a live narration explores the history of Alcatraz. Please note that this tour doesn’t stop on Alcatraz Island.
Luxury Catamaran Sailing Cruise
A relaxing way to explore the San Francisco Bay is with the Luxury Catamaran Sailing Cruise. A drink bar and snacks are available for travelers’ enjoyment as they travel under the Golden Gate Bridge, around Alcatraz Island and even past a colony of sea lions. This is a peaceful San Francisco cruise option for families, and children under 5 ride for free.
City Kayak, located on San Francisco's Embarcadero close to the San Francisco Giant's ATT Park, offers a great way to experience San Francisco from Bay level, a point of view and a unique experience you'll not soon forget.
Think Escape Casino Tour
San Francisco Bay Area
San Franciscans may be familiar with Think Escape's party buses that shuttle the late-night crowds to and from various city nightclubs, but the Cache Creek Casino Escape is a little-known gem among Bay Area destinations. With personal charter service on the luxurious Fantasy Limo Bus to Cache Creek Casino and Resort, the Cache Creek Casino Escape tour is a smart choice for San Franciscans looking for a little gaming fun or planning a large group activity