ComplianceOnline

Quality control and related contract laboratories are considered at high risk because after testing and approval, drug products and Active Pharmaceutical Ingredients (APIs) are released to the market without further check. That's the reason why the FDA and other agencies put highest emphasis on inspections of QC laboratories. Even though cGMP regulations have been in place since long time, the large number of QC related 483's and warning letters demonstrate that companies have problems with implementation.

This two day interactive in-person seminar will provide participants the regulatory background and guidelines through all critical areas of GMP compliance. This course helps attendees understand the latest requirements and also provides them templates and examples to develop inspection ready documentation.

Practical examples and interactive exercises will be dispersed into and between the presentations while 50% of the total time will be dedicated to practical sessions. During the seminar, participants will work in small groups on case studies and prepare the answers using prepared fill-in templates. After the course a large variety of tools such as SOPs, validation examples and checklists will be readily available on a dedicated website that can be used to easily implement what they have learned from the course.

Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

  • Learn about the regulatory background and GMP requirements for quality control and contract laboratories.
  • Understand and be able to explain your company’s quality plan or laboratory compliance master plan.
  • Understand the difference between GMP and non-GMP laboratories.
  • Learn how to develop inspection ready documentation.
  • Be able to train others in your organization on GMP requirements.
  • Learn how to avoid and/or respond to the FDA inspectional observations and warning letters.

Complimentary Hand-outs (Value US$ 649.00):

For easy implementation, attendees will receive free access to “Laboratory Compliance Package” as Web download.

This package includes 46 SOPs, a compliance master plan, checklist and templates that help to implement GMP requirements in laboratories (Value: US$ 649)

  • 50-Page primer: FDA GMP Compliance in Analytical Laboratories
  • Laboratory Compliance Master Plan
  • Worksheet – Laboratory Audits
  • Following Standard Operating Procedures:
  1. Corrective and Preventive Actions (s-114)
  2. Handling Out-of-Specification Results (s-115)
  3. Handling Out-of-Trend Situations (s-116)
  4. Qualification of Equipment (e-240)
  5. Validation of Spreadsheet Applications (e-264)
  6. Retention and Archiving of Electronic Records (e-315)
  7. Generation and Maintenance of SOPs for Laboratories (S-504)
  8. Change control of analytical equipment (s-509)
  9. Auditing Analytical Laboratories (s-511)
  1. Review and Approval of Analytical Test Results (s-512)
  2. Training for Laboratory Personnel (e-513)
  3. Purchasing and Receipt of Supplies for Laboratories (s-514)
  4. Quality Assessment of Laboratory Suppliers (s-515)
  5. Risk Assessment for Laboratory Systems (e-519)
  6. Laboratory Complaint Handling (s-520)
  7. Subcontracting of Testing and Calibration (s-522)
  8. Laboratory Failure Investigations (e-530)
  9. Preparation of Laboratory Working Standards (s-532)
  1. Handling of Laboratory Test Samples (s-534)
  2. Reserve Samples in Laboratories (s-535) NEW
  3. Maintenance of Laboratory Equipment (s-541)
  4. Validation of Analytical Methods (s-612)
  5. Validation of Chromatographic Methods (s-613)
  6. Handling (Certified) Reference Material (s-625)
  7. Calibration of Analytical Balances (s-641)
  8. Qualification of Refrigerators (s-644)
  9. Validation of Laboratory Computer Systems (s-656)

Who will Benefit:

This seminar will be beneficial to the following personnel in FDA regulated laboratories:

  • Analysts and lab managers
  • QA managers and personnel
  • Validation specialists
  • Regulatory affairs
  • IT professionals
  • Human resources (HR) managers and staff
  • Training departments
  • Documentation department
  • Consultants& teachers
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Day 01(8:30 AM - 5:00 PM)
  • 08.00 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • 09:00 - 09:45: FDA Regulations and Requirements Overview
    • FDA 21 CFR Part 211 and 21 CFR Part 11
    • Most frequently cited FDA 483s and warning letters
    • Requirements overview from sampling to archiving
    • Quality system requirements, e.g., ICH Q10
    • The concept and practice of risk based compliance
  • 09:45 - 10:30 (*): Planning for quality and cGMP compliance
    • Developing and using a validation master plan
    • Scope, objectives and key elements of the master plan
    • Developing and using FDA compliant SOPs
    • Using templates to generate inspection ready documentation
    • Planning for efficiency cost-effectiveness
  • 10:30 - 11:00: Break
  • 11:00 - 12:00 (*): Calibration and Qualification of Laboratory Equipment
    • FDA requirements
    • USP chapter <1058> for instrument qualification
    • Going through examples for qualification steps(DQ, IQ, OQ, PQ)
    • SOPs and deliverables for three instrument categories
    • Developing calibration and qualification protocols
  • 12:00 - 12:30 (*): Equipment Maintenance and Change control
    • Preventive maintenance; tasks, documentation
    • Planned and unplanned changes
    • Changing hardware, firmware, documentation
    • Definition and handling of like-for-like changes.
    • Requalification: time and event based
  • 12:30 - 13:30: Lunch
  • 13:30 - 15:00: Validation of Laboratory Computer Systems
    • Going through the new GAMP® guide: “A Risk based Approach to Laboratory Computerized Systems”
    • Going through a complete laboratory computer system validation from beginning to end
    • Integration the GAMP® guide with USP <1058>
    • Periodic evaluation to reduce revalidation efforts
    • Revalidation: why, what, when
  • 15:00 - 15:30: Break
  • 15:30 - 17:00 (*): Validation of Analytical Methods and Procedures
    • Parameters and tests according to ICH Q2
    • Developing a validation plan, protocols and a report
    • Setting acceptance criteria for different applications
    • Verification of compendial methods according to USP <1226>
    • Transfer of analytical procedures according to the new USP <1224>
Day 02(8:30 AM - 4:30 PM)
  • 08:30 - 09:00 AM: Sample Testing: Preparation, conduct, documentation
    • Preparing the equipment
    • Setting specifications and acceptance criteria
    • Documentation of test results
    • Review and approval
    • Not to forget: Review of electronic audit trail
  • 09:00 - 10:00 (*): Handling out of specification (OOS) test results
    • Going through the FDA OOS guide
    • Learning from recent FDA warning letters
    • Going through an OOS checklist
    • Using out of trend (OOT) data to avoid OOS results
    • Documentation and follow-up: root cause, corrective action plan, preventive action plan
  • 10:00 - 10:30: Break
  • 10:30 - 11:15 (*): Quality assurance of reference standards and other supplies
    • Supplier qualification vs. sample testing
    • Selection and assessment of suppliers
    • Retesting of materials
    • Preparing working standards from reference standards
    • Correct labeling of chemicals
  • 11:15 - 12:00: Training for GMP compliance
    • FDA requirements
    • identification of training needs
    • Developing a training plan
    • Making GMP training interesting
    • Documenting effectiveness of training
  • 12:00 - 13:00: Lunch
  • 13:00 - 14:30 (*): Ensuring Integrity of Raw Data and Other records
    • FDA Part 11 and EU-PIC/S Annex 11 requirements
    • Definition of Raw Data: Electronic vs. paper
    • Acquisition and recording of raw data
    • The importance of electronic audit trail
    • Archiving of electronic records for ‘ready retrieval’
  • 14:30 - 15:00: Break
  • 15:00 - 16:15 (*): Internal audits in preparation for FDA inspection
    • Scheduling of audits
    • FDA Inspections as model for laboratory audits
    • Going through a typical FDA laboratory inspection
    • Responding to Typical inspectional/audit deviation
    • How to avoid FDA 483s and warning letters
  • 16:15 - 16:30: Wrap up – Final questions and answers
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Dr. Ludwig Huber

Dr. Ludwig Huber
Chief Advisor - Global FDA Compliance, Labcompliance

Dr. Ludwig Huber, Ph.D., is the chief advisor and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare." He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PDA, PIC/S and several other industry organizations and national health care agencies.

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$1,699.00

Seminar One Registration (USD)

November 20-21, 2017, Singapore

$2,199.00

Seminar One Registration (USD) (With 2 Nights Stay)

November 20-21, 2017, Singapore

$7,799.00
$10,194.00 (23%)*

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November 20-21, 2017, Singapore
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The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


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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.

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Location

Hilton Singapore
581 Orchard Road,
Singapore 238883, Singapore
Tel: +65-6737-2233

November 20-21, 2017

How to Reach

General Driving Directions:

From Changi International Airport – 13 miles
  • Taxis are readily available to take you from Changi International Airport to the Hilton Singapore hotel.
  • The journey normally takes around 20 minutes from the airport to the hotel forecourt.

Other Transportation:

Bus Station
  • Many buses to the city center from Changi International Airport stop on Orchard Road, where the Hilton Singapore hotel is located. The journey normally takes around an hour.
Train Station
  • The train journey from the airport to Orchard MRT Station, the underground station nearest to Hilton Singapore hotel, normally takes around 40 minutes.

Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

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Testimonials

See What People Say About Us

Dr. Huber is very knowledgeable and the supporting material provided by him is very helpful.

SQA Compliance Auditor,

AbbVie Inc.

There is sufficient information in the seminar and the presenter is very professional.

Head of Quality,

Bayer HealthCare.

Definition of raw data and its relationship of e-signature application topic was most valuable to me as we were evaluating the gap in our company and this handy data before doing that will help us to get the requirement.

Assistant Manager,

QA, SHL Group Limited

Information and resources provided by Dr. Huber is very informative. Additional resources provided by him has practical and applicable approach. What I have learned will be helpful in reinforcing compliance in the company with QA.

Assistant Manager,

Quality Assurance, EirGenix, Inc

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Benefits of becoming a Sponsor/Exhibitor/Media Partner:

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For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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Local Attractions of Singapore

Singapore Zoo

Singapore Zoo

Since 1973, Singapore Zoo has been known for having among the most beautiful wildlife park settings in the world, where animals roam freely in open and naturalistic habitats. The Singapore Zoo spans 28 hectares within Singapore's heavily forested central catchment area. The zoo, which attracts about 1.6 million visitors per year, boasts 315 animal species, some of 16% of which are considered threatened species.

Night Safari

Night Safari

The Night Safari is the world's first nocturnal zoo and is one of the most popular tourist attractions in Singapore. Today, the award-winning park welcomes more than 1.1 million visitors a year. They come from all over the world to enjoy the unique experience of seeing over 2,500 animals in their naturalistic nighttime habitats.

Universal Studios Singapore

Universal Studios Singapore

Universal Studios Singapore is the first and only theme park in Southeast Asia. Go beyond the screen and Ride The Movies™ at Universal Studios Singapore. Only here can you experience cutting-edge rides, shows, and attractions based on your favorite blockbuster films and television series, including TRANSFORMERS The Ride: The Ultimate 3D Battle, Shrek 4-D Adventure, Madagascar: A Crate Adventure, Jurassic Park Rapids Adventure, and more!

Singapore Flyer

Singapore Flyer

The Singapore Flyer is a giant Ferris wheel in Singapore that was constructed between 2005 and 2008. Described by its operators as an observation wheel, it reaches 42 storeys high, with a total height of 165 m (541 ft), making it the world's tallest Ferris wheel, 5 m (16 ft) taller than the Star of Nanchang and 30 m (98 ft) taller than the London Eye.

Underwater World, Singapore

Underwater World, Singapore

Underwater World, Singapore is Asia's largest tropical oceanarium and one of Singapore's most popular tourist attractions. Opened in 1991, it has more than 2,500 marine animals of 250 species from different regions of the world. It is also involved in several environmental and educational projects, such as the Living in the Ocean Programme, Ocean Ambassador Programme and the Coral Club.

Boat Quay

Boat Quay

Boat Quay is a zone offering an eclectic mix of high end restaurants and alfresco dining and lively bars and pubs. Boat Quay is arguably the favorite place to “chill out” for most professionals and expatriates. Lot of options available for drinks, dining from across the world. Most popular are the dining bars along the river. After a nice dinner one can head to one of the many pubs and discs around.

Sentosa Island

Sentosa Island

Sentosa is a popular island resort in Singapore, visited by some five million people a year. Attractions include a 2 km (1.2 mi) long sheltered beach, Fort Siloso, two golf courses, two five-star hotels, and the Resorts World Sentosa, featuring the theme park Universal Studios Singapore.

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