Price: $199.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.Training Program: Good Documentation Practices and ALCOA-C
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
In this course, you will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessary to ensure product quality and product safety.
This course includes the following resources:
1. ALCOA-C Exercises Workbook
2. Why Good Documentation Practices Handout
3. Six Key Elements of Quality Data Handout
4. Investigator Warning Letter
5. Sponsor Warning Letter
6. NTF Warning Letter
This course can be used alone or as part of the full curriculum.
Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.
Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.
Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.
Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.
1. Overview of Good Documentation Practices
a. Importance of Good Documentation Practices (GDP)
b. Why are Good Documentation Practices Important?
c. Essential Documentation
d. 6 Reasons Why We Do What We Do... for Good Documentation Practices
e. ALCOA / ALCOA-C / ALCOACCEA?
f. ICH E6 R2: 4.9.0
g. Good Documentation Practices Apply; Regardless of Media Used
2. A is for Attributable
a. ALCOA-C Exercises 1a & 1b
c. GDP Tips
3. L is for Legible
a. ALCOA-C Exercise 2a & 2b
c. GDP Tips related to Legible
4. C is for Contemporaneous
a. ALCOA-C Exercise 3
c. GDP Tips Related to Contemporaneous
5. O is for Original
a. ALCOA-C Exercise 4a & 4b
c. Certified Copies & When They Are Used
d. Certified Copies for Paper or Manual Print-outs
e. Certified Copies for Paper or Print-outs from an Electronic Record
f. Copies from an Electronic System
6. A is for Accurate
a. ALCOA-C Exercise 5
c. GDP Tips Related to Accurate
7. C is for Complete
a. ALCOA-C Exercise 6
c. GDP Tips Related to Complete
8. General Procedures for GDP
a. Six Key Elements of Quality Data
b. Electronic Forms or Records Tips
c. Inspection Readiness Tips
d. Version Control and Document Labeling Tips
e. Warning Letter Examples
9. Notes to File
a. Why NTF are Used
b. Concerns about NTF
c. GDP Tips Related to NTF
d. Issues Management
e. Note to File Sample Exercise
f. Inaccurate, Incriminating, and Incomplete NTF
g. NTF Discussion - FDA
10. 10 Question Post Assessment
All clinical research professionals.
Price: $995.00 (USD)
Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device industries.
Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.
Benefits of Training with Biopharma Institute
|Immediate access to courses:||Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.|
|Self-paced, asynchronous eLearning:||24/7 access to all course materials and assessments for 12 months.|
|Open enrollment:||No prior course prerequisites or work experience required.|
|Expertise:||Courses developed by subject matter experts (SMEs) in the area being taught.|
|Current and validated:||Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.|
|Optimized for learning:||Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.|
|Secure and safe access:||Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.|
|Flexible final assessments:||Multiple-choice questions can be taken repeatedly until a passing score is achieved.|
|Direct access to certificates:||Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.|
|Verification of training:||Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.|
|Training manager access:||A proprietary portal offers access to download enrollment reports, training records, account balance, and more.|
|SCORM-compliant courses:||Courses can be delivered directly to most corporate Learning Management Systems (LMS).|
|Purchase orders (POs):||POs are accepted from all companies. Request an invoice when starting the procurement process.|
|Reimbursement:||Some employers may reimburse their employees for training expenses. Check your company's policy.|
|Financial assistance:||Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.|
|Career advancement:||Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.|
Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.